| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| DEN230068 |
09/29/2023 |
3MÖ AttestÖ eBowie-Dick Test Card 10135 3MÖ AttestÖ eBowie-Dick Card Holder 10135CH 3MÖ AttestÖ eBowie-Dick Auto-reader 1190 |
3M Company |
Michelle Larsen |
| K233257 |
09/28/2023 |
3MÖ ClarityÖAligners with Quick Attachments |
3M Company, Unitek Orthodontic Products |
Hillary Peetsch |
| K233008 |
09/22/2023 |
Cannulated Headless Bone Screws |
aap Implantate AG |
Agnieszka Mierzejewska |
| K232775 |
09/11/2023 |
ID NOW Influenza A & B 2 |
Abbott Diagnostics Scarborough, Inc. |
Jessica Stahle |
| K232669 |
09/01/2023 |
TBI |
Abbott Laboratories |
Lisa Kelly |
| K232690 |
09/01/2023 |
AmuletÖ Steerable Delivery Sheath |
Abbott Medical |
Dan Gapp |
| K233349 |
09/29/2023 |
Alinity m HSV 1 & 2 / VZV |
Abbott Molecular Inc |
Stacy Ferguson |
| K232715 |
09/05/2023 |
Distinct« Digital Pregnancy Test |
ACON Laboratories, Inc. |
Qiyi Xie |
| K233336 |
09/29/2023 |
21.3ö 3MP Color LCD Display UMD3-21B01 (MD3-21B01) |
ACULA Technology Corp |
Sheng-Sung Jian |
| K233311 |
09/29/2023 |
Acumed Wrist Plating System |
Acumed LLC |
Anusha Gedala |
| K232701 |
09/05/2023 |
Guardenia (GAR-1) |
Advanced Surgical Concepts |
Edward Hyland |
| K233126 |
09/27/2023 |
aetherSlide |
aetherAI Co., Ltd. |
Leticia Hong |
| K233253 |
09/28/2023 |
eCARTv5 Clinical Deterioration Suite (ôeCARTö) |
AgileMD, Inc. |
Borna Safabakhsh |
| K232751 |
09/08/2023 |
BriefCase-Triage |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K233312 |
09/29/2023 |
SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 |
AKTORmed GmbH |
Hanna Kafurke |
| K233324 |
09/29/2023 |
Molecular Transport Media - MTM |
ALB Luz |
Ana Luiza Bueno Luz |
| K232921 |
09/19/2023 |
DAILIES TOTAL1«; DAILIES TOTAL1« Toric; DAILIES TOTAL1« Multifocal; DAILIES TOTAL1« Multifocal Toric |
Alcon Laboratories, Inc. |
Martina Heim |
| K232784 |
09/11/2023 |
RELiZORB« |
Alcresta Therapeutics, Inc. |
Matthew King |
| K232971 |
09/21/2023 |
APRO 55 Catheter and Alembic Aspiration Tubing |
Alembic, LLC |
Lisa Yen |
| K232887 |
09/18/2023 |
Invisalign Palatal Expander System |
Align Technology, Inc. |
Sindhura Gaddamanugu |
| K232925 |
09/19/2023 |
Gastric Alimetry System |
Alimetry Ltd. |
Yaara Yarmut |
| K233024 |
09/22/2023 |
Alma Harmony |
Alma Lasers, Inc. |
Jessica Rivera-Montejo |
| K232919 |
09/19/2023 |
Ambu« aScopeÖ Gastro Large; Ambu« aBoxÖ 2 |
Ambu A/S |
Mette Andersen |
| K232823 |
09/13/2023 |
MCG-S (AM1000) |
AMCG Co., Ltd. |
Soyeon Kim |
| K233007 |
09/22/2023 |
Picosecond Nd:YAG Laser System; PICO LEGEND |
AMI Inc. |
Hae Lee Youn |
| K233183 |
09/28/2023 |
Surgical Gown (40083) |
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd |
Melody Wang |
| K232831 |
09/13/2023 |
Quiver Aspiration Pump |
Anoxia Medical Inc. |
Henry Nita |
| K233264 |
09/29/2023 |
Anthogyr INTEGRAL Guided Surgery Cassettes |
Anthogyr |
Aude Goulet |
| K233160 |
09/27/2023 |
NeuTrace EP Mapping System v.2.1 |
Anumana, Inc |
Suzanne Goodman |
| K232699 |
09/05/2023 |
Low Ejection Fraction AI-ECG Algorithm |
Anumana, Inc. |
Suzanne Goodman |
| K233229 |
09/28/2023 |
NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether |
AnX Robotica Corporation |
Tim Thomas |
| K232880 |
09/18/2023 |
Inzii Ripstop Redeployable Retrieval System |
Applied Medical Resources Corporation |
Niharika Niranjan Mirji |
| K232679 |
09/01/2023 |
CleanerÖ Pro Thrombectomy System; CleanerÖ Pro Aspiration Catheter with Handpiece; CleanerÖ Pro Aspiration Canister |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
| K232973 |
09/21/2023 |
Arthrex Knee FiberTak« Button Suture Anchor |
Arthrex Inc |
Kristi Frisch |
| K232897 |
09/18/2023 |
Arthrex Small External Fixation System |
Arthrex Inc |
Jessica Kim |
| K232742 |
09/07/2023 |
Arthrex FiberTak Suture Anchor |
Arthrex Inc. |
Kristi Frisch |
| K232755 |
09/08/2023 |
Arthrex FiberTape and TigerTape Cerclage Sutures |
Arthrex Inc. |
Ruth Segall |
| K233260 |
09/29/2023 |
Univers Revers CA Head and Adapter |
Arthrex Inc. |
Ivette Galmez |
| K232987 |
09/22/2023 |
FlowArt Valve for Vial Access |
Asset Medikal Tasarim Sanayi Ve Ticaret A.S. |
Ebru Sirali |
| K233174 |
09/28/2023 |
FaStepÖ Pregnancy Rapid Test Strip; FaStepÖ Pregnancy Rapid Test Midstream |
Assure Tech (Hangzhou) Co., Ltd. |
Shisheng Ling |
| K233359 |
09/29/2023 |
DOMINION Expandable Corpectomy System |
Astura Medical |
Parker Kelch |
| K233354 |
09/29/2023 |
WVSM Pro (Series) (500-0030-XX) |
Athena GTX, Inc. |
Sean Mahoney |
| K233170 |
09/27/2023 |
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) |
AtriCure, Inc. |
Erica Schwab |
| K232702 |
09/05/2023 |
Solo+ Tympanostomy Tube Device (TTD) |
AventaMed DAC |
Keith Jansen |
| K233342 |
09/29/2023 |
CINA-ASPECTS |
Avicenna.AI |
Stephane Berger |
| K232841 |
09/14/2023 |
Axial3D Insight |
Axial Medical Printing Limited |
Joanne Flatley |
| K233222 |
09/28/2023 |
Aygⁿn Sterilization Container Systems |
Aygun Surgical Instruments Co., Inc. |
Engin Basoglu |
| K232750 |
09/08/2023 |
BTI Interna Prosthetic Components |
B.T.I. Biotechnology Institute, S.L. |
Jose Ramon Rivero |
| K233106 |
09/27/2023 |
AccuCath AceÖ Intravascular Catheter |
Bard Access Systems, Inc. (C.R. Bard, Inc.) |
Samira Saeed |
| K232737 |
09/07/2023 |
PowerPortÖ ClearVUEÖ Slim ECG Enabled Implantable Port; PowerPortÖ ClearVUEÖ isp ECG Enabled Implantable Port; PowerPortÖ isp M.R.I.Ö ECG Enabled Implantable Port; PowerPortÖ Slim ECG Enabled Implantable Port |
Bard Peripheral Vascular, Inc. |
Kristen Ortiz |
| K233110 |
09/27/2023 |
Carnation Ambulatory Monitor |
Bardy Diagnostics, Inc. |
Ben Hornsey |
| K232904 |
09/18/2023 |
Access Ostase |
Beckman Coulter |
Kate Oelberg |
| K232791 |
09/11/2023 |
Access Intact PTH |
Beckman Coulter Inc |
Neha Desai |
| K233307 |
09/29/2023 |
Intensity Pulsed Light Therapy System |
Beijing ADSS Development Co., Ltd. |
Jijuan Wang |
| K232975 |
09/21/2023 |
Pulse Oximeter (MD300C228) |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K233010 |
09/22/2023 |
Beagank 4T Plus |
Belega Inc. |
Masayuki Okumura |
| K232954 |
09/21/2023 |
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel |
BioFire Diagnostics, LLC |
Kevin Bourzac |
| K233075 |
09/26/2023 |
ôBioGendö Interbody Fusion System 001 Cage |
BioGend Therapeutics Co. Ltd. |
Chienpei Chen |
| K232892 |
09/18/2023 |
Hp DetectÖ Stool Antigen ELISA |
Biomerica, Inc. |
Bonnie Qiu |
| K232963 |
09/21/2023 |
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 ╡g/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K232967 |
09/21/2023 |
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 ╡g/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K232977 |
09/21/2023 |
Biophotas Celluma CONTOUR |
Biophotas Inc |
Patrick Johnson |
| K232761 |
09/08/2023 |
ProNephro AKIÖ (NGAL) |
BioPorto Diagnostic Inc. |
Asger Dahlgaard |
| K233001 |
09/22/2023 |
Bioscope Neuromonitor Device |
Biosys Biyomedikal Muhendislik San. Ve Tic. A.S. |
Cemal Erdogan |
| K232991 |
09/22/2023 |
BT-1000 |
Bistos Co., Ltd. |
Goeun Choi |
| K233299 |
09/29/2023 |
ExactechGPS« System |
Blue Ortho |
Matthieu Coic |
| K233318 |
09/29/2023 |
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery Sys |
Boston Scientific Corporation |
Mr. Ian Broome |
| K233248 |
09/28/2023 |
FARADRIVEÖ Steerable Sheath |
Boston Scientific Corporation |
Nicholas Zurn |
| K233207 |
09/28/2023 |
Polaris XÖ Unidirectional Steerable Diagnostic Catheter |
Boston Scientific Corporation |
Amy Reilly |
| K232844 |
09/14/2023 |
The IQoolTM System |
BrainCool AB |
Martin Waleij |
| K232759 |
09/08/2023 |
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout |
Brainlab AG |
Sadwini Suresh |
| K232769 |
09/11/2023 |
BeaMed Laser Surgery Fibers |
BT BeaMedical Tachnoogies Ltd. (BeaMed) |
Gil Shapira |
| K232937 |
09/20/2023 |
BTL-899M |
BTL Industries, Inc |
David Chmel |
| K232808 |
09/12/2023 |
Butterfly iQ3 Ultrasound System |
Butterfly Network, Inc. |
Nathan Sabich |
| K233185 |
09/28/2023 |
MODEL P8400 Controller for C2DXÆs Hemostatix Thermal Scalpel System |
C2DX, Inc. |
Brad Beale |
| K233107 |
09/27/2023 |
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 |
Canon Medical Systems Corporation |
Paul Biggins |
| K232988 |
09/22/2023 |
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
Paul Biggins |
| K233195 |
09/28/2023 |
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
Paul Biggins |
| K232835 |
09/14/2023 |
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System |
Canon Medical Systems Corporation |
Paul Biggins |
| K233334 |
09/29/2023 |
Aquilion Serve SP (TSX-307B/1) V1.3 |
Canon Medical Systems Corporation |
Paul Biggins |
| K233031 |
09/25/2023 |
M╖Biopsy /SureCore Automatic Disposable Biopsy Needle, M╖Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M╖Biopsy /SureAim Coaxial Biopsy Needle |
Canyon Medical Inc. |
Jin Mingzhi |
| K233021 |
09/22/2023 |
BD SmartSiteÖ 13mm Vial Access Device; BD SmartSiteÖ 20mm Vial Access Device |
CareFusion |
Stefanee Smith |
| K232944 |
09/20/2023 |
CALLISTO eye |
Carl Zeiss Meditec AG |
Aditya Rao |
| K232891 |
09/18/2023 |
CARPL (CARPL) |
Carpl AI Inc. |
Josh Baker |
| K232780 |
09/11/2023 |
CC-Clip« Implant System |
CC-Instruments Inc |
Juha Ranne |
| K232717 |
09/05/2023 |
Apex Locator (AL-Pex), Apex Locator (AL-Pex+) |
Changzhou Haili Medical Co., Ltd. |
Wang Xiaofang |
| K232917 |
09/19/2023 |
Chemo Mouthpiece |
Chemo Mouthpiece, LLC |
David Yoskowitz |
| K232736 |
09/07/2023 |
Chemtrue« Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue« Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue« Multi-Panel Drug Screen Cup Test, Chemtrue« Multi-Panel Drug Screen Dip Card Test |
Chemtron Biotech, Inc. |
Jane Zhang |
| K232673 |
09/01/2023 |
Dental Glass Ceramics |
Chengdu Besmile Medical Technology Co., Ltd. |
Moushan Liu |
| K232676 |
09/01/2023 |
Dental Porcelain Powder |
Chengdu Besmile Medical Technology Co., Ltd. |
Moushan Liu |
| K232682 |
09/01/2023 |
Pre-Sintered Zirconia Coloring Liquid |
Chengdu Besmile Medical Technology Co., Ltd. |
Moushan Liu |
| K233092 |
09/26/2023 |
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) |
Chongqing Rob Linka Science and Technology Co., Ltd. |
Huirong Lu |
| K233070 |
09/26/2023 |
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) |
Chongqing Rob Linka Science And Technology Co., Ltd. |
Huirong Lu |
| K233067 |
09/26/2023 |
Wireless TENS & EMS (Model SM9110,SM9113,SM9116) |
Chongqing Rob Linka Science And Technology Co., Ltd. |
Huirong Lu |
| K233120 |
09/27/2023 |
CWM-930S, FIXER DV9 |
Chungwoo Co., Ltd. |
Su Jin Lee |
| K232986 |
09/22/2023 |
VariTrax Sternal CircumFixation System |
CircumFix Solutions, Inc. |
Ken Richardson |
| K233109 |
09/27/2023 |
TP Pivot ProÖ Needle Guide |
CIVCO Medical Solutions |
James Leong |
| K232704 |
09/05/2023 |
Clarius Ultrasound Scanner |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K233144 |
09/27/2023 |
ClearPoint Bone Screw Fiducials |
ClearPoint Neuro Inc. |
Brennan Sullivan |
| K233243 |
09/28/2023 |
ClearPoint System (Software Version 2.2) |
ClearPoint Neuro Inc. |
Brennan Sullivan |
| K233155 |
09/27/2023 |
ClearPointer Optical Navigation Wand |
ClearPoint Neuro Inc. |
Brennan Sullivan |
| K233141 |
09/27/2023 |
SmartFrame OR |
ClearPoint Neuro Inc. |
Brennan Sullivan |
| K233171 |
09/28/2023 |
PF Keep; Cad Cam Keep Block |
Clemde Sa De Cv |
Francisco Cabrera |
| K233216 |
09/28/2023 |
CLEWICU System |
Clew Medical Ltd. |
Avidgor Faians |
| K232732 |
09/07/2023 |
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 |
Co-Innovation Biotech Co., Ltd. |
Hong Feng |
| K233203 |
09/28/2023 |
Soft Tissue Augmentation Resorbable Matrix |
Collagen Matrix, Inc. |
Daniel Fernandez |
| K233101 |
09/26/2023 |
Luja Coude (20108 Male CH18 - large packaging) |
Coloplast Corp |
Troy Thome |
| K232895 |
09/18/2023 |
B-Ultrasound Diagnostic System |
Contec Medical Systems Co., Ltd. |
Xueyong Li |
| K232908 |
09/19/2023 |
Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) |
Contec Medical Systems Co., Ltd. |
Wang Donghao |
| K232893 |
09/18/2023 |
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) |
Contec Medical Systems Co., Ltd. |
Jie Xiao |
| K233177 |
09/28/2023 |
Nest VT Vitrification Device |
Cook Incorporated |
Christopher Sontag |
| K233079 |
09/26/2023 |
Zimmon« Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen« Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin« Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geen |
Cook Ireland Ltd. |
Casey Kieran |
| K232756 |
09/08/2023 |
Colibrφ |
Copan WASP S.r.l. |
Giovanna Catalano |
| K233211 |
09/28/2023 |
AVIEW CAC |
Coreline Soft Co., Ltd. |
Hye Yi Park |
| K232686 |
09/01/2023 |
CorVista« System |
CorVista Health, Inc. |
Gabrielle Zaeska |
| K233341 |
09/29/2023 |
ShileyÖ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) |
Covidien LLC |
Stephanie Reneau |
| K232809 |
09/12/2023 |
Cross Vascular RF Generator and Footswitch (optional accessory) |
Cross Vascular Inc. |
Jennifer Willner |
| K232852 |
09/14/2023 |
Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable |
Cross Vascular Inc. |
Jennifer Willner |
| K233347 |
09/29/2023 |
Verruca-Freeze« H |
CryoSurgery, Inc. |
Ronald A. McDow |
| K233049 |
09/25/2023 |
TD 200« Automated TEE Probe Disinfector with TD-12« High-Level Disinfectant with QwikCheckÖ Chemical Indicator |
CS Medical LLC |
Kendall Ashe |
| K233360 |
09/29/2023 |
Curiteva Thoracolumbar Plate System |
Curiteva, Inc. |
Eric Linder |
| K233162 |
09/27/2023 |
Freedom Peripheral Nerve Stimulator (PNS) System |
Curonix |
Hailey Rooney |
| K233237 |
09/28/2023 |
xeo+ Family |
Cutera, Inc. |
Irina Glazkova |
| K233355 |
09/29/2023 |
Cypris eXact Suturing System |
Cypris Medical |
Dan Holton |
| K233142 |
09/27/2023 |
EndoSign« Cell collection device (ES-CYT-102) |
Cyted Limited |
Neha Goel |
| K232980 |
09/21/2023 |
SpermAlign Sperm Separation Device |
CytoSwim Ltd |
Max Meissner |
| K232924 |
09/19/2023 |
T-Line« Hernia Mesh |
Deep Blue Medical Advances, Inc. |
William Perry |
| K233053 |
09/25/2023 |
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor |
Dental Imaging Technologies Corporation |
Anuradha Moholkar |
| K232994 |
09/22/2023 |
Vittra APS Unique Flow |
Dentscare LTDA |
Paula Cristine de Oliveira |
| K233233 |
09/28/2023 |
EMPHASYS Femoral Stems |
DePuy Ireland UC |
Sarah Matamisa |
| K233227 |
09/28/2023 |
VELYSÖ Robotic-Assisted Solution |
DePuy Ireland UC |
Bastien Michel d'Annoville |
| K233255 |
09/28/2023 |
CROSSNAV Navigation Enabled Instruments |
Depuy Synthes |
Daniel Meyer |
| K233256 |
09/28/2023 |
Robotic Integration Instruments |
DePuy Synthes |
Nicole Aeschbacher |
| K233254 |
09/28/2023 |
TELIGEN System Navigation Ready Instruments |
DePuy Synthes |
Marina Minnock |
| K232836 |
09/14/2023 |
Family of DIMAR DMAX NIV masks |
Dimar S.p.A |
Maurizio Borsari |
| K233231 |
09/28/2023 |
Dental Implants and Abutments |
Ditron Dental LTD |
Ariel Zuhovitzky |
| K232813 |
09/13/2023 |
Therapy EC, Therapy XT |
DMC Importacao e Exportacao de Equipamentos LTDA |
Renata Beninca Pereira |
| K233078 |
09/25/2023 |
Posterior Cervical Spine System |
Double Medical Technology Inc. |
Yan Zuo |
| K232722 |
09/05/2023 |
endo.digital Platform |
DreaMed Diabetes Ltd |
Eran Atlas |
| K232753 |
09/08/2023 |
EXPD 4343D; EXPD 3643D |
DRTECH Corporation |
Kim Minjeong |
| K233262 |
09/29/2023 |
Dukal SMS Sterilization Wrap |
Dukal LLC |
Megan Quevedo |
| K233115 |
09/27/2023 |
Hawkeye Control Unit with Eyas Endoscope |
E Surgical, LLC |
Michael Blomeyer |
| K233228 |
09/28/2023 |
Spine Navigation and Robotic-Assistance Device |
Ecential Robotics |
Amanie Yazidi |
| K232764 |
09/08/2023 |
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
ECO Medi Glove Sdn. Bhd |
Suresh Kumar |
| K232962 |
09/21/2023 |
Patient Monitor (iX10, iX12, iX15) |
Edan Instruments, Inc |
Tracy Yue |
| K232694 |
09/05/2023 |
Central Monitoring System (MFM-CMS) |
Edan Instruments, Inc. |
Tracy Yue |
| K232786 |
09/11/2023 |
Stimulation System (PA series, PR series, S series and Q series) |
Edan Instruments, Inc. |
Tracy Yue |
| K233038 |
09/25/2023 |
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s |
Edan Instruments, Inc. |
Tracy Yue |
| K232974 |
09/21/2023 |
EKGenius Smart System |
EKGenius LLC |
Shachar Barel |
| K233090 |
09/26/2023 |
DEKA AGAIN PRO family |
El. En. S.p.A. |
Paolo Peruzzi |
| K232854 |
09/15/2023 |
Leksell GammaPlan (LGP) |
Elekta Solutions AB |
Simon Sjohage |
| K232735 |
09/07/2023 |
EMA 3D |
EMA Sleep Incorporated |
Joseph Frantz |
| K232915 |
09/19/2023 |
EpiMonitor |
Empatica Srl |
Alberto Poli |
| K232865 |
09/15/2023 |
Magseed Pro Magnetic Marker System |
Endomagnetics Ltd |
Mehryar Behizad |
| K232789 |
09/11/2023 |
VIO System (V-1000) |
Enspectra Health, Inc. |
Grace Li |
| K233230 |
09/28/2023 |
See Factor CT3Ö |
Epica International, Inc. |
Craig Glaiberman |
| K233224 |
09/28/2023 |
Epilaser Pro |
Epilady 2000 LLC |
Moshe Rosenthal |
| K233118 |
09/27/2023 |
DUET-V (Model: ESK-3261DV) |
Eunsung Global Corp. |
MyeongSoo Woo |
| K233295 |
09/29/2023 |
LFR-260 |
Evolution Optiks Limited |
Raul Mihali |
| K233002 |
09/22/2023 |
BEED 2,5, BEED 3,8 |
Excelsior Resources LLC |
Christopher P Weber |
| K232912 |
09/19/2023 |
Facet Aurora Reusable Lancet Base |
Facet Technologies, LLC |
James Bonds |
| K233192 |
09/28/2023 |
Wireless Smart Thermometer |
Famidoc Technology Company Limited |
Amos Zou |
| K233148 |
09/27/2023 |
Augment Off-Axis Instrument System |
Fix Surgical |
Brian Karpinski |
| K233111 |
09/27/2023 |
ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC |
Foshan United Medical Technologies, Ltd. |
Albert Rego |
| K232878 |
09/18/2023 |
TransLoc 3D |
Foundation Fusion Solutions, LLC (dba CornerLoc) |
Robert Compton |
| K233337 |
09/29/2023 |
Freespira Breathing System |
Freespira, Inc |
Thomas Simon |
| K232953 |
09/21/2023 |
AquaBplus; AquaB LITE |
Fresenius Medical Care Renal Therapies Group, LLC |
Greg Calder |
| K232926 |
09/20/2023 |
Novalung ultimate kit (US) |
Fresenius Medical Care Renal Therapies Group, LLC |
Amelia Huynh |
| K233159 |
09/27/2023 |
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 |
Fresenius Medical Care Renal Therapies Group, LLC |
Timothy Groves |
| K233321 |
09/29/2023 |
Double Balloon Endoscope EN-840T, Over-tube TS-1214C |
FUJIFILM Healthcare Americas Corporation |
Chaitrali Kulkarni |
| K233240 |
09/28/2023 |
GERDX-System |
G-Surg GmbH |
Julian Mair |
| K233084 |
09/26/2023 |
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K232822 |
09/13/2023 |
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K233200 |
09/28/2023 |
XPLUS 35 Series (XPLUS 35, XPLUS 35FD) |
Gemss Healthcare Co., Ltd. |
Jiho Park |
| K232672 |
09/01/2023 |
EasyScreen Gastrointestinal Parasite Detection Kit |
Genetic Signatures Limited |
Neralie Coulston |
| K233152 |
09/27/2023 |
GENIOVA aligners |
Geniova Technologies Sociedad Limitada |
Antonio Baselga de la Vega |
| DEN230067 |
09/28/2023 |
Chronos« |
Germitec |
Vincent Gardes |
| K232942 |
09/20/2023 |
G-VitriÖ Vitrification Freeze Media; G-VitriÖ Vitrification Thawing Media |
Gimbo Medical Technology Shenzhen Co., Ltd. |
Leo Guo |
| K232829 |
09/13/2023 |
Versalock Rib and Sternum Plates System |
GM Dos Reis Industria e Comercio Ltda |
Guilherme Esteves Pontes |
| K233236 |
09/28/2023 |
Radiance V5 |
GMV Soluciones Globales Internet S.A.U. |
Carlos Illana |
| K232968 |
09/21/2023 |
Grande Medical Masks, Model SF-600 |
Golden Grande Corp. |
Hsin Hui Tseng |
| K232966 |
09/21/2023 |
FISIOWARM 7.0 |
Golden Star Srl |
Tiziaria Borrelli |
| K232678 |
09/01/2023 |
Digital Thermometer, Model T28, T28L |
Guangdong Genial Technology Co., Ltd. |
Yu Jun |
| K232713 |
09/05/2023 |
Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Jerry Fan |
| K233130 |
09/27/2023 |
Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Jerry Fan |
| K233056 |
09/25/2023 |
EpiZact |
GuideStar Medical Devices |
Michael Dolphin |
| K233275 |
09/29/2023 |
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) |
Gyrus ACMI, Inc |
Andrea Curria |
| K233027 |
09/25/2023 |
NanoZoomer S360MD Slide scanner system |
Hamamatsu Photonics K.K. |
Shinichi Fujisaka |
| K233019 |
09/22/2023 |
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx |
Hangzhou AllTest Biotech Co.,Ltd |
Rosa Wu |
| K233125 |
09/27/2023 |
Zirconia Block |
Hangzhou IVISTA Medical Devices Co., Ltd. |
Yao Cheng |
| K233263 |
09/29/2023 |
Disposable Trocars |
Hangzhou Kangji Medical Instrument Co., Ltd. |
Martin Sun |
| K233277 |
09/29/2023 |
Filter Needle for Single Use |
Hangzhou Qiantang Longyue Biotechnology Co., LTD |
Chunyu Wang |
| K233287 |
09/29/2023 |
Vent Vial Adapter |
Hangzhou Qiantang Longyue Biotechnology Co., Ltd |
Chunyu Wang |
| K233284 |
09/29/2023 |
Vial Adapter with Filter |
Hangzhou Qiantang Longyue Biotechnology Co., Ltd |
Chunyu Wang |
| K232934 |
09/20/2023 |
Sunsphere |
Hangzhou Yangshun Medical Technology Co.,Ltd |
Hui Dong |
| K232933 |
09/20/2023 |
AirKEE P900 |
HealKEE Medical Pte Ltd |
William Tao |
| K232886 |
09/18/2023 |
INFILOOP« Fixed Loop UHMWPE Suture Titanium Button |
Healthium Medtech Limited |
Pankaj Dawar |
| K232709 |
09/05/2023 |
Diode laser therapy device |
Hebei Zhemai Technology Co., Ltd |
Yuting Qu |
| K232716 |
09/05/2023 |
Q-Switched Nd:Yag laser |
Hebei Zhemai Technology Co., Ltd |
Yuting Qu |
| K232708 |
09/05/2023 |
Intense pulsed light therapy device |
Hebei Zhemai Technology Co.,Ltd |
Yuting Qu |
| K233247 |
09/28/2023 |
Heuron ICH |
Heuron Co., Ltd. |
Inah Jeong |
| K233346 |
09/29/2023 |
Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180m |
HG Innovations Ltd |
M Umran Rafiq |
| K233351 |
09/29/2023 |
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cab |
HG Innovations Ltd |
M Umran Rafiq |
| K233123 |
09/27/2023 |
SILKRO |
Hironic Co., Ltd. |
Gwijin Lee |
| K232675 |
09/01/2023 |
Heating Tens, FT-615 |
Hivox Biotek Inc. |
Leslie Peng |
| K233352 |
09/29/2023 |
Aptima HCV Quant Dx Assay |
Hologic, Inc. |
Howard Liu |
| K232946 |
09/20/2023 |
Yumizen H2500 |
Horiba ABX Sas |
Caroline Ferrer |
| K233261 |
09/29/2023 |
Global Modular Replacement System |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
Denise Daugert |
| K233241 |
09/28/2023 |
SOLACE Sacroiliac Fixation System |
HT Medical LLC dba Xenix Medical |
Teresa Cherry |
| K232796 |
09/12/2023 |
LUOFUCON« Collagen Particles (Collagen Wound Dressing) |
Huizhou Foryou Medical Devices Co., Ltd. |
Taylor Deng |
| K233036 |
09/25/2023 |
Ultrasonic Surgical System |
Hunan Handlike Minimally Invasive Surgery Co., Ltd. |
Yang Bihong |
| K233140 |
09/27/2023 |
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) |
Hygea Medical Technology Co., Ltd. |
Jinping Duan |
| K233136 |
09/27/2023 |
Hygeia Express Powered Breast Pump |
Hygeia II Medical Group, Inc. |
Brett Nakfoor |
| K232760 |
09/08/2023 |
Swoop« Portable MR Imaging System« |
Hyperfine, Inc. |
Christine Kupchick |
| K233134 |
09/27/2023 |
I.T.S. INS Proximal Femur Nail |
I.T.S. GmbH |
Florian Grill |
| K233215 |
09/26/2023 |
icotec Anterior Cervical Plate System |
Icotec AG |
Marina Hess |
| K232792 |
09/11/2023 |
icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurnÖ TLIF Lumbar Cage) |
icotec AG |
Marina Hess |
| K232790 |
09/11/2023 |
KONG«-TL VBR System and KONG« C VBR System |
icotec AG |
Marina Hess |
| K233018 |
09/22/2023 |
PICOSECOND Nd:YAG Laser System |
IDS, Ltd. |
Kwang Yeong Ahn |
| K232898 |
09/18/2023 |
QuantisalÖ Oral Fluid Collection Device |
Immunalysis Corporation |
Shubhajit Mitra |
| K233083 |
09/26/2023 |
Osteon Precision Milled Suprastructure |
Implant Solutions PTY LTD (aka Osteon Medical) |
Farah Rahman |
| K233089 |
09/26/2023 |
NeoSpan« Compression Implant System |
In2Bones USA, LLC |
Christine Scifert |
| K233069 |
09/26/2023 |
Removal System Large Bore 60 cc Syringe |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K233358 |
09/29/2023 |
SCoV-2 Ag Detect Rapid Test |
InBios International, Inc. |
Annabel Tsai |
| K232833 |
09/13/2023 |
HALO AP Dx |
Indica Labs, Inc. |
Michele Fredrickson |
| K233081 |
09/26/2023 |
NUVENTUS NV.CÖ Dental Implant System |
Infinitum Eta Ltd. |
Kobi Shakarchi |
| K232947 |
09/20/2023 |
SIRAÖ RFA Electrosurgical Device |
Innoblative Designs, Inc. |
Katherine Crowley |
| K233157 |
09/27/2023 |
VaporMAX LDD; MOJo LDD; MegaJOULE LDD |
InnovaQuartz LLC |
Stephen Griffin |
| K233292 |
09/29/2023 |
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress |
inomed Medizintechnik GmbH |
Tomasz Moszkowski |
| K232730 |
09/07/2023 |
Aventus Thrombectomy System |
Inquis Medical |
Mojgan Saadat |
| K232788 |
09/11/2023 |
INSPIRA ART100 |
Inspira Technologies Oxy B.H.N Ltd. |
Dganit Litinsky |
| K233252 |
09/28/2023 |
Straumann CARES Visual and Nova Dental CAD |
Institut Straumann AG |
Gordon Dodds |
| K232741 |
09/07/2023 |
SmartAdjust(TM) technology |
Insulet Corporation |
Alexander Hamad |
| K232890 |
09/18/2023 |
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) |
Integra LifeSciences Production Corporation |
Kali Sacco |
| K232787 |
09/11/2023 |
ScanNav Anatomy Peripheral Nerve Block |
Intelligent Ultrasound Limited |
Bhaskar Chikkanna |
| K232692 |
09/05/2023 |
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) |
Intradin (Shanghai) Machinery Co., Ltd |
Mark Li |
| K232773 |
09/11/2023 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc |
Connor McCarty |
| K232984 |
09/22/2023 |
Ion Endoluminal System (IF1000) |
Intuitive Surgical, Inc. |
Jyoti Singh |
| K232762 |
09/08/2023 |
dS Breast Coil 7ch 1.5T |
Invivo Corporation (Business Trade Name: Philips) |
Liselotte Kornmann |
| K233077 |
09/26/2023 |
FlashHeal 2 (FlashHeal 2.0) |
InWound ApS |
Otto ╪mann |
| K233344 |
09/29/2023 |
Regenalase Laser System |
IPG Medical |
Samuel D Wade |
| K233294 |
09/29/2023 |
Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM |
ITP Innovative Tomography Products GmbH |
Dominik FrΣmke |
| K233163 |
09/27/2023 |
ZENEX Implant System_Short |
Izenimplant Co., Ltd. |
Mi-Kyung Kwon |
| K232957 |
09/21/2023 |
Sterile and Non-Sterile Ultrasound Gels |
Jianerkang Medical Co., Ltd |
Zhang Zhigang |
| K233190 |
09/28/2023 |
ENFit Adaptor |
Jiangsu Caina Medical Co., Ltd. |
Camel Zhou |
| K232781 |
09/11/2023 |
Safety Sliding Blood Collection Set |
Jiangsu Caina Medical Co., Ltd. |
Camel Zhou |
| K232866 |
09/15/2023 |
Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) |
Jiangsu Channel Medical Device Co., Ltd |
Eric Huang |
| K232703 |
09/05/2023 |
Disposable Bipolar Forceps |
Jiangsu Hope Biomedical Science&Technology Co., Ltd. |
Shaote Geng |
| K232783 |
09/11/2023 |
Power wheelchair (Model: JMPW-01W) |
Jiangsu Jumao x-Care Medical Equipment Co.,Ltd |
Weixia Shi |
| K232881 |
09/18/2023 |
Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder |
Jiangsu Kangbao Medical Equipment Co., Ltd |
Wenbin Fan |
| K232825 |
09/13/2023 |
Disposable Sphincterotome |
Jiangsu Vedkang Medical Science and Technology Co., Ltd. |
Yulu Shi |
| K232752 |
09/08/2023 |
Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL- |
Jiangsu Vedkang Medical Science and Technology Co., Ltd. |
Zheng Xinxing |
| K233196 |
09/28/2023 |
Medihub Prostate |
JLK Inc. |
Dongmin Kim |
| K233332 |
09/29/2023 |
Statera-CÖ Spinal System |
K&J Consulting Corp. |
Milan George |
| K232877 |
09/15/2023 |
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-CÖ Stand Alone System |
K&J Consulting Corporation |
Milan George |
| K232911 |
09/19/2023 |
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) |
Karl Storz Endovision, Inc |
Thomas Ostrowski |
| K232857 |
09/15/2023 |
KARL STORZ ICG Imaging System |
Karl Storz SE & Co. Kg |
Alita McElroy |
| K233333 |
09/29/2023 |
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit |
KARL STORZ SE & CO. KG |
Emily Rhiel |
| K233285 |
09/29/2023 |
KATANA Zirconia ONE For IMPLANT |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K233245 |
09/28/2023 |
MagnetOs Flex Matrix |
Kuros Biosciences B.V. |
Hen Baron |
| K233149 |
09/27/2023 |
CATHTONG III Tapered PICC Catheter |
L&Z US, Inc. |
James Li |
| K233313 |
09/29/2023 |
Keikku Electronic stethoscope |
Lapsi Health Holding B.V |
Koskinen Katja |
| K233356 |
09/29/2023 |
Illusion Aligner Pro: Illusion Aligner FLX |
Laxmi Dental Export PVT. LTD |
Sameer Merchant |
| K232985 |
09/22/2023 |
24HR513C |
LG Electronics Inc. |
Jinhwan Jun |
| K232827 |
09/13/2023 |
LightForce Orthodontic System |
LightForce Orthodontics |
Jeffrey Roberts |
| K233251 |
09/28/2023 |
NOxBOXi Nitric Oxide Delivery System |
Linde Gas & Equipment Inc. |
Dave Loflin |
| K233122 |
09/27/2023 |
High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) |
Litu Tech Ltd. |
Guangzhao Liu |
| DEN230069 |
09/29/2023 |
Mi-CHORD System |
LSI SOLUTIONS, Inc. |
Christopher B. Miller |
| K233301 |
09/29/2023 |
ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories |
Lumenis Be Ltd. |
Shlomit Segman |
| K233217 |
09/28/2023 |
Mimics Cardiac Planner |
Materialise N.V. |
Victoria Becheva |
| K232767 |
09/11/2023 |
Nautilus VF ECMO Oxygenator |
MC3 Inc. |
Martha Rumford |
| K232733 |
09/07/2023 |
Mbrace Cable |
Medacta International S.A. |
Stefano Baj |
| K233172 |
09/28/2023 |
NextARÖ Spine Platform |
Medacta International S.A. |
Stefano Baj |
| K233266 |
09/29/2023 |
MEDIBLU ECG SYSTEM |
Mediblu Medical LLC |
Fernando Ramon |
| K232945 |
09/20/2023 |
Trio-CT¡« Triple Lumen Catheter w/ Curved Extensions |
Medical Components Inc. (Dba MedComp) |
Danielle McKinney |
| K232905 |
09/19/2023 |
Medline UNITE« REFLEX« Nitinol Staple Kit |
Medline Industries, LP |
Jennifer Mason |
| K233151 |
09/27/2023 |
PluroGel« Antimicrobial Burn and Wound Dressing, PluroGel« Burn and Wound Dressing (OTC) |
Medline Industries, LP |
Dinah Rincones |
| K233320 |
09/29/2023 |
LINQ IIÖ Insertable Cardiac Monitor (LNQ22) |
Medtronic, Inc. |
Dustin Hawbaker |
| K232858 |
09/15/2023 |
ORskin Blue |
Megabay S.A. |
Oren Gabay |
| K233361 |
09/29/2023 |
Sunny Cup and Applicator |
Menstrual Mates |
Cindy Belardo |
| K233326 |
09/29/2023 |
Merge Hemo, Model RCSV2 |
Merge Healthcare Incorporated |
Carol Nakagawa |
| K233268 |
09/29/2023 |
Impress Angiographic Catheter |
Merit Medical Systems, Inc. |
Gamaliel Figueroa |
| K232889 |
09/18/2023 |
METICULY Patient-specific titanium maxillofacial mesh implant |
Meticuly Co., Ltd. |
Peeranoot Lohwongwatana |
| K233221 |
09/28/2023 |
Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) |
Metro Optics of Austin, Inc. |
Steve Webb |
| K232670 |
09/01/2023 |
HiCardi+ H100 |
Mezoo Co., Ltd. |
Junghwan Park |
| K233095 |
09/26/2023 |
S21 OTC Transcutaneous Electrical Nerve Stimulator |
Micro Current Technology, Inc. |
David Suzuki |
| K232810 |
09/12/2023 |
Dental Handpiece, Wireless Endodontic Handpiece, endoit |
Micro-NX Co., Ltd. |
Haim Yoon |
| K232955 |
09/21/2023 |
Numen Coil Embolization System; NumenFR Detachment System |
MicroPort NeuroTech (Shanghai) Co., Ltd. |
Jiayin Sun |
| K233026 |
09/22/2023 |
Midmark Smart M9« Sterilizer, Midmark Smart M11« Sterilizer |
Midmark Corporation |
Adam Clutter |
| K232862 |
09/15/2023 |
MIM û Monte Carlo Dosimetry |
MIM Software Inc. |
Sydney Lindner |
| K233322 |
09/29/2023 |
Mochida Nerve Cuff |
Mochida Pharmaceutical Co., Ltd. |
Akiko Koarai |
| K232922 |
09/19/2023 |
Pure-Vu EVS System |
Motus GI Medical Technologies Ltd. |
Mark Pomeranz |
| K233137 |
09/27/2023 |
Ticare Dental Implant Systems |
Mozo Grau S.A. |
Beatriz Santos |
| K233030 |
09/25/2023 |
BoneMRI |
MRIguidance B.V |
David Sparks |
| K233006 |
09/22/2023 |
MyndMove, MyndMove 2.0 |
MyndTec Inc. |
Yesmil Pena |
| K233308 |
09/29/2023 |
Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) |
NAKANISHI INC. |
Masaaki Kikuchi |
| K233288 |
09/29/2023 |
NLZ Built-In Motor System |
Nakanishi Inc. |
Masaaki Kikuchi |
| K233117 |
09/27/2023 |
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) |
Nakanishi Inc. |
Masaaki Kikuchi |
| K233068 |
09/26/2023 |
Disposable Surgical Gown |
Nanning TECBOD Biological Technology Co.,Ltd. |
Bing Yao Chen |
| K233080 |
09/26/2023 |
HealthFLD |
Nano-X AI Ltd. |
Neta Sherman |
| K232864 |
09/15/2023 |
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II |
Nantong Egens Biotechnology Co.,Ltd. |
Ouweijun . |
| K233150 |
09/27/2023 |
NET BRAND Osteosynthesis Nailing System |
Narang Medical LTD. |
Vivek Narang |
| K233166 |
09/27/2023 |
NET Recovery Corp/NET Device |
Net Recovery |
Joe Winston |
| K232688 |
09/01/2023 |
NQ TMS for MDD (NQv1-MU-01) |
NeuroQore, Inc. |
Mehran Talebinejad |
| K233293 |
09/29/2023 |
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System« |
NeuroSigma, Inc. |
Colin P. Kealey, M.D. |
| K233025 |
09/22/2023 |
Revolution External Plating System |
New Standard Device dba Metalogix |
Rachel Grimes |
| K233234 |
09/28/2023 |
PressON Spinal Fixation System |
Nexus Spine, LLC |
Jared Crocker |
| K232774 |
09/11/2023 |
Wearable Breast Pump,Model S18 |
Ningbo Dearevery Electronic Technology Co., LTD |
Kelong Zhang |
| K232842 |
09/14/2023 |
Balloon Inflation System |
Ningbo HicRen Biotechnology Co., Ltd. |
Qian Jia |
| K232969 |
09/21/2023 |
Disposable Hemostatic Clips |
Ningbo Xinwell Medical Technology Co., Ltd |
Lei Xi |
| K233208 |
09/28/2023 |
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium |
Nobel Biocare AB |
Bernice Jim |
| K232680 |
09/01/2023 |
fMRI Hardware System |
NordicNeuroLab AS |
Chandana Gurung Bhandari |
| K232674 |
09/01/2023 |
PainFreeze II |
Nuance Medical, LLC |
Neal Hartman |
| K233357 |
09/29/2023 |
EsoCool Thermal Regulation Catheter |
Nuvaira, Inc. |
John Carline |
| K232803 |
09/12/2023 |
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) |
NxStage Medical Inc. |
Denise Oppermann |
| K233213 |
09/28/2023 |
NxStage PureFlow Solution |
NxStage Medical, Inc. |
Caitlin Kalda |
| K233343 |
09/29/2023 |
SteriCap Safety Needle; VitreJect Safety Needle |
OcuJect, LLC |
Leonid Lerner |
| K232930 |
09/20/2023 |
VERVE |
OculoMotor Technologies |
Chang Yaramothu, Ph.D. |
| K232997 |
09/22/2023 |
EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 |
Olympus Medical Systems Corporation |
Shinichiro Kawachi |
| K233046 |
09/25/2023 |
Electrical Neuromuscular Stimulator, Cure Trio |
Oriental Inspiration Limited |
Francis Ko |
| K233093 |
09/26/2023 |
Balanced Knee« System TriMax PS Plus Tibial Insert |
Ortho Development Corporation |
Drew Weaver |
| K232771 |
09/11/2023 |
Montage Flowable Settable, Resorbable Bone Paste |
Orthocon, Inc. |
Aniq Darr |
| K232998 |
09/22/2023 |
Montage- XT Settable, Resorbable Hemostatic Bone Putty |
Orthocon, Inc. |
Howard Schrayer |
| K233105 |
09/27/2023 |
RESPONSEÖ Rib and Pelvic System |
OrthoPediatrics Corp. |
Yan Li |
| K233199 |
09/28/2023 |
ROSA« Shoulder System |
Orthosoft Inc (d/b/a Zimmer CAS) |
Sankalp Dere |
| K233302 |
09/29/2023 |
OSSIOfiber« Compression Staple |
Ossio Ltd. |
Taly Lindner |
| K233198 |
09/28/2023 |
OSSIOfiber« Threaded Trimmable Fixation Nails |
OSSIO Ltd. |
Taly Lindner |
| K233194 |
09/28/2023 |
TS Abutment System |
Osstem Implant Co., Ltd. |
Seungju Kang |
| K233167 |
09/27/2023 |
LW Implant System û Abutment |
Ossvis Co., Ltd. |
Woo Jin Lee |
| K233335 |
09/29/2023 |
Tablo« Hemodialysis System |
Outset Medical, Inc. |
Claire Bao |
| K232776 |
09/11/2023 |
Tablo« Hemodialysis System; TabloCartÖ with Prefiltration Drawer |
Outset Medical, Inc. |
Joshua Mink |
| K232824 |
09/13/2023 |
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOF |
Owens & Minor (O&M) Halyard, Inc. |
Caitlin Senter |
| K232807 |
09/12/2023 |
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) |
Owens & Minor (O&M) Halyard, Inc. |
Angela L. Bunn |
| K232777 |
09/11/2023 |
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) |
Owens & Minor (O&M) Halyard, Inc. |
Caitlin Senter |
| K232812 |
09/12/2023 |
Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62 |
Owens & Minor (O&M) Halyard, Inc. |
Angela L. Bunn |
| K233022 |
09/22/2023 |
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Sm |
Owens & Minor (O&M) Halyard, Inc. |
Anureet Singh |
| K232849 |
09/14/2023 |
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) |
Owens & Minor (O&M) Halyard, Inc. |
Gabriel Dockery |
| K232820 |
09/13/2023 |
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) |
Owens & Minor (O&M) Halyard, Inc. |
Anureet Singh |
| K232806 |
09/12/2023 |
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) |
Owens & Minor (O&M) Halyard, Inc. |
Anureet Singh |
| K232894 |
09/18/2023 |
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) |
Owens & Minor (O&M) Halyard, Inc. |
Anureet Singh |
| K232902 |
09/18/2023 |
EVA15 insufflator |
Palliare Ltd. |
John O'Dea |
| K232740 |
09/07/2023 |
Paltop Short Implants |
Paltop Advanced Dental Solutions, Ltd |
Nancy DeAngelo |
| K232838 |
09/14/2023 |
Monkey RingsTM External Fixation System |
Paragon 28, Inc. |
Edward Wells-Spicer |
| K232860 |
09/15/2023 |
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
PENTAX of America, Inc. |
William Goeller |
| K233201 |
09/28/2023 |
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) |
Penumbra, Inc. |
Sheina Rajkumar |
| K232950 |
09/20/2023 |
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle |
Perfect Medical Industry (VN) Co., Ltd. |
Nancy Phan |
| K233043 |
09/25/2023 |
Smart Scope« CX |
Periwinkle Technologies Pvt. Ltd |
Veena Moktali |
| K233265 |
09/29/2023 |
Monotime and Optime R |
Peters Surgical |
Ellen Henke Knupp |
| K233348 |
09/29/2023 |
16 Breast Coil |
Philips Medical System Nederlands B.V. |
Shruti Sancheti |
| K232910 |
09/19/2023 |
CombiDiagnost R90 |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K233204 |
09/28/2023 |
Philips IntelliSite Pathology Solution 5.1 |
Philips Medical Systems Nederland B.V. |
Liselotte Kornmann |
| K233331 |
09/29/2023 |
MediOMx |
PMX Inc. |
Girish Srinivasan |
| K232903 |
09/18/2023 |
Legend X Platform |
Pollogen Ltd |
Karen Smith |
| K232719 |
09/05/2023 |
ProMIS Extension Rod System |
Premia Spine Ltd. |
Dorit Winitz |
| K233273 |
09/29/2023 |
C&B Ceramic; C&B Permanent; C&B Interim |
Prevest Denpro Limited |
Atul Modi |
| K233132 |
09/27/2023 |
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) |
PRIMUS Sterilizer Company, LLC |
Patrick Hansen |
| K232738 |
09/07/2023 |
BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) |
PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla |
Sandor-Csaba Ats |
| K233100 |
09/26/2023 |
QIAstat-Dx« Respiratory Panel Plus |
QIAGEN GmbH |
Autumn Collasius |
| K232804 |
09/12/2023 |
FibriCheck |
Qompium nv |
Jo Van der Auwera |
| K233091 |
09/26/2023 |
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) |
Qura S.r.l. |
Raffaella Tommasini |
| K232779 |
09/11/2023 |
QUEX ED; QUEX S |
QX World Ltd |
Lilla Strobel |
| K233226 |
09/28/2023 |
FlexView Diagnostic (v1.1.20) |
Radical Imaging, LLC |
Rob Lewis |
| DEN230064 |
09/19/2023 |
BraidE Embolization Assist Device |
Rapid Medical Ltd. |
Ina Gutman |
| K233350 |
09/29/2023 |
SINC Support Catheter |
Reflow Medical, Inc. |
Lori Grace |
| K232677 |
09/01/2023 |
Reia pessary |
Reia, LLC |
Kaitlin Maier |
| K233258 |
09/28/2023 |
Shadow Knotless All-Suture Anchors |
Responsive Arthroscopy LLC |
Garrett Ahlborg |
| K232763 |
09/08/2023 |
Electrode Handpieces (VCT, RFTV, BMDT series) |
RF Medical Co., Ltd |
Kwang S Choi |
| K233082 |
09/26/2023 |
TopCEM Dual Cure Resin Cement |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| K232990 |
09/22/2023 |
AÆTOMICÖ Nitinol Fixation System |
RMR Ortho, LLC |
Joe Ritz |
| K233060 |
09/25/2023 |
Elecsys Folate III |
Roche Diagnostics |
Amy Pierce |
| K233034 |
09/25/2023 |
Mobility+ Enteral Feeding System OTC |
Rockfield Medical |
Orla Connaughton |
| K233143 |
09/27/2023 |
PiXel8-Reveal |
Rohrer Aesthetics |
Mark Rohrer |
| K233147 |
09/27/2023 |
PiXel8-RF |
Rohrer Aesthetics |
Mark Rohrer |
| K233099 |
09/26/2023 |
Gladiator |
Rohrer Aesthetics, LLC |
Mark Rohrer |
| K233329 |
09/29/2023 |
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set |
Route 92 Medical, Inc. |
Kirsten Valley |
| K233076 |
09/26/2023 |
Laser Speckle Imaging System (RFLSI CZW) |
RWD Life Science Co., Ltd. |
Xuhong Wang |
| K232821 |
09/13/2023 |
S.I.N. Dental Implant System |
S.I.N. - Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K233153 |
09/27/2023 |
Traus SSG10 Surgical System |
Saeshin Precision Co., Ltd. |
Gung San Nam |
| K232938 |
09/20/2023 |
Traus SSG30 Surgical System |
Saeshin Precision Co., Ltd. |
Gung San Nam |
| K233112 |
09/27/2023 |
HM70 EVO Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
So-yeon Jang |
| K233225 |
09/28/2023 |
SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) |
Schoelly Fiberoptic GmbH |
Sandra Baumann |
| K232668 |
09/01/2023 |
Cove Strip, OsteoCove Strip |
SeaSpine Orthopedics Corporation |
Cindy Toyama |
| K233220 |
09/28/2023 |
EnCor EnspireÖBreast Biopsy System (E4115, E4230); EnCorÖ Breast Biopsy Driver (DRENCOR); EnCorÖ MRI Breast Biopsy Driver (DRENCORMR); EnCorÖ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCorÖ MRI Breast Biop |
SenoRx, Inc. |
Kathryn Swanstrom |
| K232982 |
09/22/2023 |
EMS Sculpt Machine |
Shandong Huamei Technology Co.,Ltd. |
Dong Yugui |
| K233042 |
09/25/2023 |
Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Shandong Intco Medical Products Co, Ltd. |
Max Li |
| K233205 |
09/28/2023 |
Distal Access Catheter |
Shanghai HeartCare Medical Technology Co.,Ltd. |
Tianrong Hong |
| K232996 |
09/22/2023 |
Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) |
Shanghai Iatrical-Ti Technologies Co Ltd. |
Haozhang Zhong |
| K232712 |
09/05/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K233209 |
09/28/2023 |
uOmnispace.CT |
Shanghai United Imaging Healthcare Co., Ltd. |
Gao Xin |
| K233176 |
09/28/2023 |
uOmnispace.MI |
Shanghai United Imaging Healthcare Co., Ltd. |
Gao Xin |
| K233186 |
09/28/2023 |
uOmnispace.MR |
Shanghai United Imaging Healthcare Co., Ltd. |
Gao Xin |
| K232885 |
09/18/2023 |
Dawn Diode Laser System |
Shanghai Wonderful Opto-Electrics Tech Co., Ltd. |
Lily Zhou |
| K233304 |
09/29/2023 |
Omnimax S3, Omnimax S4 |
SharpLight Technologies Ltd |
Rada Trifonov |
| K232989 |
09/22/2023 |
Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) |
Shenzhen AOJ Medical Technology Co., Ltd |
Jack Wang |
| K233119 |
09/27/2023 |
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T |
Shenzhen Beacon Display Technology Co., Ltd. |
Li Yafei |
| K232939 |
09/20/2023 |
IPL Hair Removal Device |
Shenzhen Borria Technology Co., Ltd |
Tiantian Wang |
| K232932 |
09/20/2023 |
Intense Pulse Light Therapeutic Apparatus |
Shenzhen Greatro Electronic Technology Co., Ltd. |
Xinhua Yue |
| K233035 |
09/25/2023 |
Electronic Muscle Stimulator (Model MP01) |
Shenzhen Hengbosi Industrial Co., Ltd. |
Zhiwei Chen |
| K232797 |
09/12/2023 |
Hygenix |
Shenzhen Hygenix Industrial Co., Ltd |
Jia Du |
| K233114 |
09/27/2023 |
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) |
Shenzhen Idea Light Limited |
Liu Nicole |
| K233040 |
09/25/2023 |
EMS/TENS Massager Device |
Shenzhen IMDK Medical Technology Co., Ltd. |
Yuan Xia |
| K233146 |
09/27/2023 |
Blood Pressure Monitor |
Shenzhen Jamr Technology Co., Ltd. |
Haiyu Zhang |
| K232863 |
09/15/2023 |
Radiant Renewal Skincare Wand (HD-15, HD-15A) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
Alain Dijkstra |
| K232816 |
09/13/2023 |
Electrocardiograph, model: ECG301 |
Shenzhen Le Medical Technology Co., Ltd. |
Wuyaxiong . |
| K232721 |
09/05/2023 |
Lifetech Cardio Temporary Pacemaker |
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. |
Stephy Pan |
| K232846 |
09/14/2023 |
Light Based Hair Removal Device |
Shenzhen MEIK Beauty Industry Co., Ltd |
Xuegang Zhang |
| K232772 |
09/11/2023 |
Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2, |
Shenzhen Plinma Technology Co. Ltd. |
Zhang Mongdi |
| K232995 |
09/22/2023 |
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; El |
Shenzhen Roundwhale Technology Co., Ltd. |
Zeng Chunming |
| K232965 |
09/21/2023 |
Leg Massager (Models:RP-ALM070H, RP-ALM071H) |
Shenzhen Ruiyi Business Technology Co., Ltd. |
Derric Bai |
| K232845 |
09/14/2023 |
IPL Cooling Hair Removal Device |
Shenzhen Siken 3D Technology Development Co., Ltd. |
Jingquan Liu |
| K233016 |
09/22/2023 |
Dental Glass Ceramics |
Shenzhen Yurucheng Dental Materials Co., Ltd. |
Hongfei Liao |
| K233161 |
09/27/2023 |
BeautiLink SA |
Shofu Dental Corporation |
Mauro Malzyner |
| K232800 |
09/12/2023 |
Navigation Tracking Instruments |
SI-BONE, Inc. |
Daniel Cher |
| K233242 |
09/28/2023 |
Atellica« CH High Sensitivity C-Reactive Protein 2 (hCRP2) |
Siemens HealthCare Diagnostics Inc. |
Anthony Calabro |
| K233050 |
09/25/2023 |
ADVIA Centaur« TSH3-Ultra II (TSH3ULII) |
Siemens Healthcare Diagnostics, Inc. |
Kelly Scuderi |
| K232856 |
09/15/2023 |
Syngo Carbon Clinicals |
Siemens Healthcare GmbH |
Ramadas Ramadas |
| K232744 |
09/07/2023 |
syngo Virtual Cockpit (VB10A) |
Siemens Healthcare GmbH |
Jiayan Liu |
| K232899 |
09/18/2023 |
AI-Rad Companion Organs RT |
Siemens Medical Solutions U.S.A. |
Kira Morales |
| K233270 |
09/29/2023 |
AcuNav Crystal Ultrasound Catheter |
Siemens Medical Solutions USA, Inc. |
Bongsoo Cho |
| K232765 |
09/08/2023 |
MAGNETOM Cima.X Fit |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K232799 |
09/12/2023 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
Monsuru Bello |
| K233013 |
09/22/2023 |
2-Way 100% Silicone Cleartract Catheter |
Silq Technologies Corporation |
D. Verne Sharma |
| K232805 |
09/12/2023 |
Kronos Electrocautery Device |
Single Pass, Inc. |
Bill Colone |
| K232847 |
09/14/2023 |
SiOxD Wound Matrix |
SiOxMed, LLC. |
Adam Jorgensen |
| K233154 |
09/27/2023 |
SkyOPSÖ Orthopedic Plate System |
Sky Surgical LLC |
Jeff Sander |
| K232667 |
09/01/2023 |
OR3O Dual Mobility Liners |
Smith & Nephew, Inc. |
Madison Padgett |
| K232943 |
09/20/2023 |
Hypodermic Needle-Pro« EDGEÖ Safety Device with Low Dead Space Syringe |
Smiths Medical ASD Inc |
Ben Rappaport |
| K232698 |
09/05/2023 |
NemoScan |
Software Nemotec S.L. |
Miguel Del Moral |
| K233104 |
09/26/2023 |
SofWave System |
Sofwave Medical Ltd. |
Ruthie Amir |
| K232999 |
09/22/2023 |
Lyric4 Hearing Aid |
Sonova AG |
Kateryna Konovalenko |
| K232726 |
09/06/2023 |
External Hex Implant System |
Southern Implants (Pty) Ltd |
Colin Saffy |
| K233191 |
09/28/2023 |
TotalTi ACDF by SAGICO |
Spinal Analytics & Geometrical Implant Co, LLC |
James J. Gibson |
| K233113 |
09/27/2023 |
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) |
STARmed Co., Ltd. |
Honggeun Lee |
| K233280 |
09/29/2023 |
SteadyTemp |
SteadySense GmbH |
Werner Koele |
| K232826 |
09/13/2023 |
Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813) |
STERIS |
Carroll Martin |
| K232951 |
09/21/2023 |
BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield |
Steris |
Carroll Martin |
| K233187 |
09/28/2023 |
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) |
Steris |
Anthony Piotrkowski |
| K233065 |
09/26/2023 |
V-PRO maX 2 Low Temperature Sterilization System |
Steris |
Jennifer Nalepka |
| K232918 |
09/19/2023 |
enspire 300 Series Automated Endoscope Reprocessor |
Steris Corporation |
Nalepka Jennifer |
| K232914 |
09/19/2023 |
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) |
STERIS Corporation |
Jennifer Nalepka |
| K232795 |
09/12/2023 |
Led Mask Platinum Exclusive MD |
STG24 CO.,LTD. |
Seojeong Kim |
| K232758 |
09/08/2023 |
Comatryx OTC |
Strukmyer Medical, LLC. |
Christian Quinto |
| K233327 |
09/29/2023 |
1788 4K Camera System with Advanced Imaging Modality |
Stryker Endoscopy |
Michelle Stephens |
| K232683 |
09/01/2023 |
Knotilus+ PEEK Knotless Anchor |
Stryker Endoscopy |
Madison Mutchler |
| K233300 |
09/29/2023 |
POWEReam 1/4 Drive |
Stryker Instruments |
Marie Gildea |
| K233098 |
09/26/2023 |
MYOTouch Muscle Stimulator |
SunMed LLC. |
Robert Yamashita |
| K233315 |
09/29/2023 |
HipXpert and HipInsight System |
Surgical Planning Associates, Inc |
Stephen Murphy |
| K232684 |
09/01/2023 |
Surgify Halo |
Surgify Medical OY |
Jukka Kreander |
| K232725 |
09/06/2023 |
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor |
Suzhou Endophix Co., Ltd. |
Juan Wu |
| K232941 |
09/20/2023 |
Megaloop Button System |
Suzhou Endophix Co., Ltd. |
Juan Wu |
| K232888 |
09/18/2023 |
Disposable Laryngeal Electrodes |
Suzhou Haishen Medical Device Associates Co., Ltd |
Leyi Dai |
| K233276 |
09/29/2023 |
Reusable Blood Pressure Cuff |
Suzhou Minhua Medical Apparatus Supplies Co., LTD |
Michael Ying |
| K232981 |
09/21/2023 |
Synq Software Version 1.3 |
Synaptive Medical Inc. |
Ahmed Hamed |
| K233271 |
09/29/2023 |
OsseOne Dental Implant System |
Synoross DBA OsseOne |
Gennady Shapiro |
| K233184 |
09/28/2023 |
T2Bacteria« Panel |
T2 Biosystems, Inc. |
Rachel Gilbert |
| K233133 |
09/27/2023 |
Talis EMR with Talis +ACG (Talis EMR with +ACG) |
Talis Clinical, LLC |
William Murphy |
| K233044 |
09/25/2023 |
Tandem Mobi insulin pump with interoperable technology |
Tandem Diabetes Care Inc. |
Louise Focht |
| K233020 |
09/22/2023 |
TauTona Pneumoperitoneum Assist Device (TPAD) |
TauTona Group Research & Development, Co. LLC |
Michael Blanchette |
| K232970 |
09/21/2023 |
Hem-o-lok« Ligating Clips |
Teleflex Medical |
Hope West |
| K232992 |
09/22/2023 |
10THERMA |
Tentech Inc. |
Dongok Han |
| K233316 |
09/29/2023 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K233249 |
09/28/2023 |
APPRAISE-HRI |
The Surgeon General, Department of the Army (TSG-DA) |
Emily Badraslionglu |
| K232802 |
09/12/2023 |
TMINIÖ Miniature Robotic System |
Think Surgical, Inc. |
Anand Patel |
| K232828 |
09/13/2023 |
IMAGEnet6 Ophthalmic Data System |
Topcon Corporation |
Ryota Kitawaki |
| DEN230061 |
09/12/2023 |
allay Nerve Cap |
Tulavi Therapeutics |
Corinne Bright |
| K233017 |
09/22/2023 |
TM Plating System |
Tyber Medical, LLC. |
Lisa Boyle |
| K232693 |
09/05/2023 |
Tyber Medical Distal Radius Plating System |
Tyber Medical, LLC. |
Lisa Boyle |
| K232920 |
09/19/2023 |
RELIEFÖ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEFÖ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm |
Ureteral Stent Company |
Mike Bunker |
| K232837 |
09/14/2023 |
Uro-G HD Flexible Cystoscope |
UroViu Corporation |
Thom Lawson |
| K232923 |
09/19/2023 |
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) |
Varian Medical Systems Inc. |
Lynn Allman |
| K232949 |
09/20/2023 |
Kelowna GYN and Crook Prostate Templates |
Varian Medical Systems, Inc |
Dr. Lynn Allman |
| K232870 |
09/15/2023 |
TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) |
Varian Medical Systems, Inc |
Lynn Allman |
| K232879 |
09/18/2023 |
Roche Digital Pathology Dx (VENTANA DP 200) |
Ventana Medical Systems, Inc. |
Cameron Smith |
| K232830 |
09/13/2023 |
Vibrant System |
Vibrant Ltd. |
Martha Bezalel, Ph.D. |
| K233108 |
09/27/2023 |
VinDr-Mammo |
VinBigData Joint Stock Company |
Nguyet (Jun) Phan |
| K233325 |
09/29/2023 |
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) |
Visionary Optics LLC |
Donald Sanders |
| K233062 |
09/26/2023 |
BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx |
VivaChek Biotech (Hangzhou) Co., Ltd |
Jessica Chen |
| K233058 |
09/25/2023 |
VivaChek Link Plus Blood Glucose Monitoring System |
VivaChek Biotech (Hangzhou) Co., Ltd. |
Mark Qian |
| K232976 |
09/21/2023 |
VUZE System |
VUZE Medical Ltd. |
David Tolkowsky |
| K233096 |
09/26/2023 |
PRESSUREALERT« Pressure Monitoring System |
Walgreen Health Solutions, LLC |
Dawn Bolles |
| K233094 |
09/26/2023 |
Wellead« Latex Foley Catheter |
Well Lead Medical (Hainan) Co., Ltd. |
Jenny Zhu |
| K233054 |
09/25/2023 |
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator |
Well-Life Healthcare Limited |
Jenny Hsieh |
| K232875 |
09/15/2023 |
Vial Adapter 20mm |
West Pharma Services IL, Ltd. |
David Ceretti |
| K233158 |
09/27/2023 |
Copra Smile, Copra Supreme Hyperion |
Whitepeaks Dental Solutions GmbH |
Oliver Puckert |
| K233064 |
09/26/2023 |
Copra Supreme |
Whitepeaks Dental Solutions GmbH |
Oliver Puckert |
| K232952 |
09/21/2023 |
Copran Zri |
Whitepeaks Dental Solutions GmbH |
Oliver Puckert |
| K232928 |
09/20/2023 |
DeepContour (V1.0) |
Wisdom Technologies., Inc. |
Xie George Xu |
| K233223 |
09/28/2023 |
OGmend« Implant Enhancement System |
Woven Orthopedic Technologies |
Brandon Bendes |
| K233259 |
09/29/2023 |
Xerosyn |
XeroThera Inc |
Noel Rolon |
| K233238 |
09/28/2023 |
Air Pressure Therapy System (Model:VU-IPC4M) |
Xiamen Weiyou Intelligent Technology Co., Ltd. |
Yong Sun |
| K232749 |
09/08/2023 |
DOOPANG |
Ybrain, Inc. |
Kiwon Lee |
| K232710 |
09/05/2023 |
Dental Cone-beam Computed Tomography |
Yian Medical Technology (Haining) Co., Ltd. |
Lili Yan |
| K232839 |
09/14/2023 |
Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear |
Yung Sheng Optical Co., Ltd. |
Wen-Han Chen |
| K233210 |
09/28/2023 |
sam CS Long Duration Ultrasound Device |
ZetrOZ Systems, LLC |
Sabrina Lewis |
| K232793 |
09/11/2023 |
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets |
Zevex, Inc. |
Christopher Dodge |
| K233037 |
09/25/2023 |
Sterile Hypodermic Needles for Single Use |
Zhejiang Kindly Medical Device Co., Ltd. |
Zhang Qian |
| K232814 |
09/13/2023 |
Electronic Blood Pressure Monitor |
Zhuhai Yueja Medical Device Technology Co.,Ltd. |
Feng Yan |
| K232815 |
09/13/2023 |
Wrist Blood Pressure Monitor |
Zhuhai Yueja Medical Device Technology Co.,Ltd. |
Feng Yan |
| K233182 |
09/28/2023 |
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) |
Zibo Kaiyue Mould Technology Co., Ltd |
Cindy Lee |
| K232691 |
09/01/2023 |
Polibond |
Zirkonzahn Srl |
Sorana Siclovan |
