| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K223435 |
04/13/2023 |
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System |
Abbott Diabetes Care Inc. |
Katherine L. Doll Kanne |
| K230411 |
04/14/2023 |
Dragonfly OpStarÖ Imaging Catheter |
Abbott Medical |
Derek Pike |
| K222909 |
04/07/2023 |
Axiostat Gauze |
Advamedica Inc. |
Leo Mavely |
| K223310 |
04/05/2023 |
Antimicrobial Silicone PHMB Foam Wound Dressing |
Advanced Medical Solutions Limited |
Kay Mcgrath |
| K230785 |
04/20/2023 |
Precision1, Precision1 for Astigmatism |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K230695 |
04/10/2023 |
APRO 70 Catheter and Alembic Aspiration Tubing |
Alembic, LLC |
Lisa Yen |
| K223398 |
04/27/2023 |
Gastric Alimetry System |
Alimetry Ltd. |
Yaara Yarmut |
| K230732 |
04/11/2023 |
Eagle S/Saevo Slim/D700 Slim |
Alliage S/A Industrias Medica Odontol≤gico. |
Daniel Camargo |
| K223816 |
04/07/2023 |
Dental CT Scanner AXR |
Alliage S/A Industrias Medico Odontol≤gica. |
Daniel Camargo |
| K220763 |
04/13/2023 |
ALPCO Calprotectin Immunoturbidimetric Assay |
ALPCO |
Chris Wisherd |
| K223564 |
04/17/2023 |
X-CUBE 50, X-CUBE 60 |
Alpinion Medical Systems Co., Ltd. |
Boyeon CHO |
| K230766 |
04/19/2023 |
Altus Spine Monaco Pedicle Screw System |
Altus Spine |
Rand Baker |
| K223838 |
04/12/2023 |
CatalysÖ Precision Laser System |
AMO Manufacturing USA, LLC |
Laarni Ricafort |
| K230698 |
04/18/2023 |
Anivia SG1000 Pump Console |
AMPTD Inc. |
John Sasso |
| K220274 |
04/24/2023 |
Kisar Stratford SI Screw System |
Anjali Investments L.L.C |
Amit Patel |
| K223240 |
04/03/2023 |
Annalise Enterprise CTB Triage Trauma |
Annalise-AI Pty Ltd |
Haylee Bosshard |
| K230694 |
04/13/2023 |
NaviCam Xpress Stomach System, NaviCam Xpress System |
AnX Robotica Corp. |
Cathlena Martinez |
| K230272 |
04/27/2023 |
Renuvion« APR Handpiece |
Apyx Medical Corporation |
Angela Huber |
| K223176 |
04/10/2023 |
Cleaner PlusÖ Thrombectomy System, Cleaner PlusÖ Aspiration Catheter, Cleaner PlusÖ Handpiece with 65cm Maceration Wire, Cleaner PlusÖ Handpiece with 135cm Maceration Wire, Cleaner PlusÖ Aspiration Canister |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
| K193514 |
04/13/2023 |
AUTION MAX AX-4060 Urinalysis System |
Arkray Inc. |
Hideko Kosaka |
| K223373 |
04/07/2023 |
EnivoÖ |
Aroa Biosurgery Ltd. |
Tina O'Brien |
| K212220 |
04/20/2023 |
ArtFX Spinal Fixation System |
ArtFX Medical LLC |
Ozgen Ozfidan |
| K230366 |
04/10/2023 |
Arthrex Univers Revers Monoblock Stem Size 4/33 |
Arthrex Inc. |
Tiffany Mentzel |
| K230568 |
04/01/2023 |
FiberTak Suture Anchor |
Arthrex Inc. |
Erikka Edwardsen |
| K222690 |
04/24/2023 |
SmartGUIDE deflectable hydrophilic guidewire |
Artiria Medical SA |
Guillaume Petit-Pierre |
| K223634 |
04/28/2023 |
Customized Abutment |
Arum Dentistry Co., Ltd. |
Boyeon Lim |
| K221742 |
04/21/2023 |
CONNEQT PULSE |
Atcor Medical |
Toni Hofhine |
| K220454 |
04/03/2023 |
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application |
Avation Medical, Inc. |
Manish Vaishya |
| K230594 |
04/25/2023 |
Tigereye ST CTO-Crossing Catheter |
Avinger, Inc. |
Thomas Lawson |
| K220854 |
04/14/2023 |
TrachCuff Cuff Controller |
AW Technologies ApS |
Adam Hansen |
| K223640 |
04/07/2023 |
Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) |
AxoGen Corporation |
Jonathan White |
| K222996 |
04/26/2023 |
Access PCT |
Beckman Coulter, Inc |
Neha Desai |
| K221493 |
04/05/2023 |
MicroScan Prompt Inoculation System-D |
Beckman Coulter, Inc. |
Sharon Cullen |
| K222370 |
04/02/2023 |
SpO2 Extension Cable |
Beijing Rongrui-Century Science & Technology Co., Ltd. |
Calen Chen |
| K230719 |
04/13/2023 |
BIOFIRE« SPOTFIRE« Respiratory (R) Panel Mini |
Biofire Diagnostics, LLC |
Kevin Bourzac |
| K221390 |
04/28/2023 |
BNLE Access Guidewire |
Biomerics NLE |
Jason Albers |
| K223830 |
04/11/2023 |
Ultrasound System 2300 |
BK Medical Aps |
Inesa Cernajute |
| K230503 |
04/25/2023 |
Polaris XÖ Catheter Cable, BlazerÖ Dx-20 Catheter Cable |
Boston Scientific |
Stephanie Andre |
| K223552 |
04/19/2023 |
Brainlab Elements û Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial |
Brainlab AG |
Sadwini Suresh |
| K223734 |
04/27/2023 |
ENT EM |
Brainlab AG |
Esther Moreno Garcia |
| K220142 |
04/04/2023 |
BRM Digitalis Spacer |
BRM Extremities Srl |
Andrea De Maglio |
| K230705 |
04/11/2023 |
POT PTCA Balloon Dilatation Catheter |
BrosMed Medical Co., Ltd. |
Crystal Lee |
| K221865 |
04/14/2023 |
BTL-094 |
BTL Industries Inc. |
David Chmel |
| K230223 |
04/25/2023 |
iCAC Device |
Bunkerhill, Inc |
Nishith Khandwala |
| DEN210055 |
04/07/2023 |
The N-SWEAT Patch |
Candesant Biomedical, Inc. |
Scott A. Wilson |
| K222865 |
04/03/2023 |
M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle |
Canyon Medical Inc. |
Huiqi Jiang |
| K230028 |
04/03/2023 |
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly |
Cardinal Health200, LLC |
Katy Piper |
| K223088 |
04/07/2023 |
BD SmartSiteÖ Needle-Free Connector |
CareFusion |
Jacob Lee |
| K222200 |
04/13/2023 |
CIRRUS HD-OCT |
Carl Zeiss Meditec Inc |
Vidita Desai |
| K222330 |
04/24/2023 |
The Heart Seat |
Casana Care, Inc. |
Kara Johnson |
| K222676 |
04/25/2023 |
Ceevra Reveal 3 |
Ceevra, Inc. |
Ken Koster |
| K223763 |
04/11/2023 |
ZeptoLink IOL Positioning System |
Centricity Vision, Inc. |
Neal Hartman |
| K230164 |
04/10/2023 |
TENS and EMS Stimulation (OTC) |
Changsha Yuwen Medical Equipment Co., Ltd |
Chen Dahui |
| K230829 |
04/26/2023 |
TENS7000 Rechargeable (Model:TENS7000 Rechargeable) |
Chongqing Rob Linka Science And Technology Co., Ltd. |
Yixuan Li |
| K223332 |
04/12/2023 |
Task Force CORE |
CNSystems Medizintechnik GmbH |
Raphael Gunacker |
| K230136 |
04/24/2023 |
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) |
CompAI Healthcare (Suzhou) Co.,ltd |
Xueqiao Wang |
| K230140 |
04/24/2023 |
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) |
CompAI Healthcare (Suzhou) Co.,ltd |
Xueqiao Wang |
| K223509 |
04/14/2023 |
Compremium Compartment Compressibility Monitoring System (CPM#1) |
Compremium AG |
Vincent Baumann |
| K230844 |
04/27/2023 |
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert |
Conformis Inc. |
Mary Kruitwagen |
| K230547 |
04/27/2023 |
PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter |
ConMed Corporation |
Ali AbuSaleh |
| K230318 |
04/07/2023 |
Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring |
Corcym S.r.l. |
Silvia Contadini |
| K230704 |
04/24/2023 |
RAIN SheathÖ Tibial Pedal Introducer |
Cordis US Corp. |
Wai Morgan |
| K223705 |
04/14/2023 |
EndoflipTM 300 |
Covidien LLC |
Liron Bar Yaakov |
| K220513 |
04/25/2023 |
NITRO Interbody Fusion Cage System Family |
CTL Medical Corporation |
Sean Suh |
| K221963 |
04/27/2023 |
Cumulus Functional Neurophysiology Platform |
Cumulus Neuroscience Limited |
Caroline Kirwan |
| K230689 |
04/05/2023 |
T-FIXÖ 3DSI Joint Fusion System |
Cutting Edge Spine, LLC |
Kyle Kuntz |
| K230911 |
04/27/2023 |
Braun Skin i.expert |
CyDen Limited |
Adam Stephens |
| K222352 |
04/27/2023 |
Epildream HP 4000 MED |
D.E.A Project S.r.1. |
Nico Guerini |
| K222781 |
04/11/2023 |
Augmento |
Deeptek Medical Imaging Private Limited |
Kallol Sen |
| K223550 |
04/10/2023 |
DMX |
Del Medical, Inc. |
Greg Geary |
| K230341 |
04/06/2023 |
ACRIFIX |
DeltaMed GmbH |
Michael Zimmermann |
| K223784 |
04/18/2023 |
Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 100+, SEG 150+, SEG200, SEG200+ |
Deltronix Equipamentos Ltda |
Carlos Paulim |
| K230218 |
04/25/2023 |
DD Solid Connect« CAD/CAM Abutments (further DD Ti-Base 2CUT series) |
Dental Direkt GmbH |
Patrick Berz |
| K222604 |
04/21/2023 |
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S |
dentona AG |
Andreas Foerster |
| K230056 |
04/25/2023 |
MiVuÖ Esophageal Endo Cap |
Diversatek Healthcare |
Jim Prinster |
| K214009 |
04/05/2023 |
D╖Kaptain PTA High Pressure Balloon Dilatation Catheter |
DK Medical Technology Co., Ltd. |
Shi Quan |
| K221118 |
04/05/2023 |
CO2 Mainstream Sensor |
Draegerwerk AG & Co. KGaA |
Lyubov Lange |
| K223768 |
04/20/2023 |
RadiForce RX270 |
EIZO Corporation |
Hiroaki Hashimoto |
| K223501 |
04/21/2023 |
ViewFinder Software Version 1.1 |
Elaitra Ltd |
Stephen Morrell |
| DEN220082 |
04/20/2023 |
Bateman Bottle |
Empower Medical Devices |
Jared Finney |
| K230169 |
04/06/2023 |
EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert |
Encore Medical, L.P. dba Enovis |
Trey Thorsen |
| K230387 |
04/13/2023 |
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S) |
Ethicon Endo-Surgery, LLC |
Ekta Patel |
| K230468 |
04/21/2023 |
EzDent Web |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K230264 |
04/13/2023 |
Ezra Flash |
Ezra AI, Inc. |
David Girard |
| K222887 |
04/10/2023 |
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor |
Famidoc Technology Company Limited |
Amos Zou |
| K220981 |
04/20/2023 |
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe |
Fehling Surgical Instruments, Inc. |
Hayden Hosch |
| K222197 |
04/06/2023 |
F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K222012 |
04/05/2023 |
FAQ 101 |
Foreo, Inc. |
Laura Hoshue |
| K222006 |
04/03/2023 |
Sclerotherapy & Endoscopic Needles |
G-Flex Europe SPRL |
Thierry Cremer |
| K223212 |
04/27/2023 |
Precision DL |
GE Healthcare |
George Mashour |
| K223531 |
04/06/2023 |
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) |
GE Healthcare Finland Oy |
Joel Kent |
| K230807 |
04/20/2023 |
Deep Learning Image Reconstruction |
GE Healthcare Japan Corporation |
He Haibo |
| K223300 |
04/21/2023 |
Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument |
GEOTEK Medikal Ltd sti |
Latif Iba |
| K221042 |
04/19/2023 |
Renova RP Centesis Pump |
GI Supply, Inc. |
Erika Parry |
| K230565 |
04/20/2023 |
HILINEÖ Fixation System |
Globus Medical Inc. |
Jennifer Antonacci |
| K223868 |
04/26/2023 |
PYXIS 3D Titanium Cage System |
GS Medical Co. Ltd. |
Sam Camp |
| K221983 |
04/27/2023 |
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color |
Guangdong Kingfa Sci. & Tech. Co., LTD. |
Xiaoge Yu |
| K222677 |
04/05/2023 |
Intermittent nelaton catheter for single use |
Hangzhou Jimushi Meditech Co., Ltd. |
Fenlong Wu |
| K222739 |
04/06/2023 |
Disposable Insulin Pen Needle |
Hantech Medical Device Co., Ltd. |
Rachel Jin |
| K222004 |
04/28/2023 |
INTEGRATE -C Interbody Fusion System |
HAPPE Spine |
Jenna Hollern |
| K222023 |
04/06/2023 |
RayFlow |
Hexacath |
Anthony Molliex |
| K222636 |
04/28/2023 |
ET Abutment System |
Hiossen Inc. |
Peter Lee |
| K223069 |
04/21/2023 |
Modular Rotating Hinge Knee Systems and Compatible Components |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
Margaret Klippel |
| K230313 |
04/06/2023 |
QUANTUM Patient Specific Instrumentation (PSI) System |
In2Bones SAS |
Sabina Ahaddad |
| K230494 |
04/18/2023 |
ClotTriever BOLD Catheter |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K223210 |
04/27/2023 |
ClotTriever XL Catheter |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K213584 |
04/04/2023 |
Reprocessed NRG Transseptal Needle |
Innovative Health, LLC. |
Rick Ferreira |
| K223892 |
04/27/2023 |
DentMix VPS Impression Material |
Innovative Product Brands, Inc. |
Shane Nielsen |
| K223372 |
04/24/2023 |
Omnipod GO Insulin Delivery Device |
Insulet Corporation |
Lauren Davis |
| K230393 |
04/13/2023 |
UniCam Evo Software |
Inter Medical Medizintechnik GmbH |
Hans-Guenter Osiek |
| K222185 |
04/13/2023 |
Stratus Infusion Catheter |
InterVene, Inc. |
Jeff Elkins |
| K230033 |
04/05/2023 |
Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical Inc. |
Mike Yramategui |
| K230811 |
04/21/2023 |
Digital Intraoral X-Ray Sensor |
iRay Imaging Technology (Haining) Limited |
Jeffrey Wu |
| K230658 |
04/07/2023 |
SKOUT« system |
Iterative Scopes Inc. |
Dennis Francoeur |
| K213825 |
04/28/2023 |
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A |
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
Wei Yan |
| K223662 |
04/20/2023 |
Neodent Implant System - Helix Short Surgical Kit Cases |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Barbara Uzae |
| K213078 |
04/27/2023 |
Myolift QT |
Johari Digital Healthcare Limited |
Pooja Johari |
| K223566 |
04/14/2023 |
ELITAÖ Femtosecond Laser System, ELITAÖ Patient Interface |
Johnson & Johnson Surgical Vision, Inc. |
Amanda Houston |
| K222350 |
04/13/2023 |
Sterile Nitrile Surgical Gloves Powder Free |
JR Engineering & Medical Technologies (M) SDN. BHD. |
Ganesan Subramaniam |
| K230107 |
04/05/2023 |
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 |
Kam Yuen Plastic Products Ltd. |
Anna Dan |
| K223520 |
04/27/2023 |
UNIDRIVE SIII System |
Karl Storz-Endoscopy-America, Inc. |
Alita McElroy |
| K230906 |
04/25/2023 |
Konicaminolta DI-X1 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K220677 |
04/28/2023 |
Kurin Blood Culture Collection Set with Kurin Lock Technology |
Kurin, Inc, |
Neal Hartman |
| K230808 |
04/21/2023 |
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System |
Kyocera Medical Technologies, Inc. |
Scott Rucker |
| K222210 |
04/21/2023 |
AEON Endoscopic Stapler |
Lexington Medical Inc. |
Rainer Maas |
| K230845 |
04/27/2023 |
32HL512D, 31HN713D, 32HQ713D |
LG Electronics Inc. |
Jinhwan Jun |
| K230597 |
04/28/2023 |
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K230336 |
04/05/2023 |
CurrentBody SkinÖ Led Hair Regrowth(Model: MZ-07) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K230042 |
04/28/2023 |
Q-Rejuvalight Pro Facewear (Model: P19-0023) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K230575 |
04/07/2023 |
Limbus Contour |
Limbus AI Inc. |
Jon Giambattista |
| K223932 |
04/26/2023 |
SafeAir combi (SFR-combi-US) |
LiNA Medical ApS |
Jaroslaw Mrowczynski |
| K230539 |
04/27/2023 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K230499 |
04/26/2023 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K223577 |
04/17/2023 |
Localite TMS Navigator TS |
Localite GmbH |
Arno Schmitgen |
| K230868 |
04/13/2023 |
SPOTFIRE« RSP Pos & Neg Controls, SPOTFIRE« RSP Positive Control, SPOTFIRE« RSP Negative Control |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K211153 |
04/20/2023 |
Inomax DSIR |
Mallinckrodt Manufacturing LLC |
David Trueblood |
| K213676 |
04/16/2023 |
Masimo Rad-G with Temperature |
Masimo Corporation |
Sahar Bagheri |
| K221802 |
04/03/2023 |
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) |
Mawi DNA Technologies |
Bassam EL-Fahmawi |
| K221734 |
04/01/2023 |
Maxtec MaxO2 ME+p |
Maxtec, LLC |
Sidra Hankins |
| K230064 |
04/07/2023 |
Mazor X System (Mazor X Stealth Edition) |
Mazor Robotics Ltd. |
Rishi Sinha |
| K230544 |
04/17/2023 |
SnugFit All-Suture Anchor extension |
Medacta International S.A. |
Stefano Baj |
| K230640 |
04/06/2023 |
Affinity FusionÖ Oxygenator System |
Medtronic Inc. |
Aj Thakkar |
| K223168 |
04/19/2023 |
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with BalanceÖ Biosurface |
Medtronic Inc. |
Anna Wetherille |
| K230553 |
04/26/2023 |
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application |
Medtronic, Inc. |
Kerry Luyster |
| K223630 |
04/05/2023 |
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System |
Medtronic, Inc. |
Kerry Luyster |
| K211556 |
04/05/2023 |
N2 |
MegaGen Implant Co., Ltd. |
Jae Ho Lee |
| K230385 |
04/04/2023 |
Ballancer Platinum (1222) |
Mego Afek |
Yunger Reuven |
| K222829 |
04/17/2023 |
Curian« Shiga Toxin |
Meridian Bioscience Inc. |
Heather Planck |
| K230010 |
04/13/2023 |
ADSEAL Plus |
Meta Biomed Co., LTD. |
Suk Song Oh |
| K222694 |
04/27/2023 |
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) |
MicroVention, Inc. |
Ganesh Balachandar |
| K223774 |
04/06/2023 |
Contour ProtΘgΘAI |
MIM Software Inc. |
Lynn Hanigan |
| K221220 |
04/19/2023 |
Montross Extremity Medical Hemi Implant System |
Montross Extremity Medical |
William Montross |
| DEN220033 |
04/10/2023 |
MISHA Knee System |
Moximed, Inc. |
Nancy E. Issac |
| K230098 |
04/13/2023 |
TrusanaÖ |
Myerson, LLC |
James H Swartout |
| K222934 |
04/28/2023 |
Nanox.ARC |
Nano-X Imaging Ltd. |
Erez Meltzer |
| K230029 |
04/04/2023 |
NeuroStar Advanced Therapy System (Version 3.7) |
Neuronetics |
Amanda Pentecost |
| K221303 |
04/11/2023 |
Neuspera Nuity System |
Neuspera Medical Inc. |
Alexander Yeh |
| K223677 |
04/28/2023 |
Titanium Abutment Blank Nobel Biocare N1 TCC |
Nobel Biocare AB |
Bernice Jim |
| DEN220059 |
04/17/2023 |
NTX100 Tonic Motor Activation (NTX100 ToMAc) System |
Noctrix Health, Inc. |
Shriram Raghunathan |
| K223785 |
04/14/2023 |
N9+ |
Nonagon Ltd. |
Orly Maor |
| K220288 |
04/19/2023 |
NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector |
NP Medical Inc |
Krishna Govindarajan |
| K221142 |
04/21/2023 |
Kyphoplasty Balloon System |
OK MediNet Korea Co., Ltd. |
Kang Yoo Jin |
| K230552 |
04/26/2023 |
MR DWI/FLAIR Measurement V1.0 |
Olea Medical |
Nathalie Palumbo |
| K222584 |
04/26/2023 |
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 |
Olympus Medical Systems Corporation |
Shinichiro Kawachi |
| K221974 |
04/16/2023 |
EpiFinder |
Omeq Medical Ltd. |
Lior Margalit |
| K230819 |
04/21/2023 |
OmniGuide RFID Surgical Laser Fibers |
Omni-Guide Holdings, Inc. |
Carlos O Acosta |
| K230424 |
04/12/2023 |
Omnia Medical Coupler-AÖ Anterior Lumbar Plate System; Omnia Medical Coupler-LÖ Lateral Lumbar Plate System |
Omnia Medical, LLC |
Troy Schifano |
| K223238 |
04/20/2023 |
STARband 3D |
Orthomerica Products Inc. |
David C Kerr |
| K230764 |
04/18/2023 |
OsteoCentric Integrated Hip Fastener System |
OsteoCentric Technologies |
Todd Evans |
| K220261 |
04/24/2023 |
NEST-C Interbody System |
Paonan Biotech Co., Ltd. |
Penny Huang |
| K223458 |
04/06/2023 |
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems |
Philips Medical Systems Nederland B.V. |
Ioana Ulea |
| K230972 |
04/28/2023 |
Ingenia Elition and MR 7700 MR Systems |
Philips Medical Systems, Nederland B.V. |
Ioana Ulea |
| K230789 |
04/21/2023 |
Knee+ |
Pixee Medical |
Lucie PΘcheur |
| K220345 |
04/14/2023 |
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terrage |
Plasmapp Co., Ltd. |
Seung Hun Lee |
| K222738 |
04/13/2023 |
Point implant system |
PointNix Co., Ltd |
Chang Nam Lee |
| K220312 |
04/12/2023 |
Polyfusion IV Administration Sets |
Poly Medicure Limited |
Ramdas Sharma |
| K222291 |
04/21/2023 |
Paradigm System |
Proprio, Inc. |
Niyi Asimolowo |
| K230772 |
04/17/2023 |
Quantib Prostate |
Quantib BV |
Floor van Leeuwen |
| K223879 |
04/13/2023 |
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) |
Quara S.r.l. |
Raffaella Tommasini |
| K230685 |
04/14/2023 |
AutoContour Model RADAC V3 |
Radformation, Inc. |
Kurt Sysock |
| K230429 |
04/17/2023 |
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device |
Rapid Medical Ltd. |
Orit Yaniv |
| K230753 |
04/11/2023 |
RCT800 |
Ray Co., Ltd. |
Changhwan Lee |
| K230783 |
04/21/2023 |
Anatase Spine Surgery Navigation System |
Remex Medical Corp. |
Wang Cheng-Hsiung |
| K220456 |
04/07/2023 |
Elecsys FT4 IV |
Roche Diagnostics |
Bin Sun |
| K223530 |
04/11/2023 |
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set |
Route 92 Medical, Inc. |
Kirsten Valley |
| K230069 |
04/06/2023 |
S.I.N. Dental Implant System |
S.I.N. û Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K230084 |
04/21/2023 |
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
So-yeon Jang |
| K211748 |
04/19/2023 |
Selux AST System; Model AST Gen 1.0 |
Selux Diagnostics, Inc |
Eric Stern |
| K213170 |
04/18/2023 |
SENSOSEEG Depth Electrodes |
Sensomedical Labs LTD |
Sama Tarazi |
| K230816 |
04/21/2023 |
Intense Pulsed Light Treatment System |
Shangdong Huamei Technology Co., Ltd. |
Yugui Dong |
| K222261 |
04/20/2023 |
Flexible Video-Choledochoscope System |
Shanghai SeeGen Photoelectric Technology Co., Ltd |
Yihua Ma |
| K230097 |
04/06/2023 |
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 |
Shenzhen BSX Technology Electronics Co., Ltd. |
Hong Li |
| K230035 |
04/05/2023 |
BioSciÖ Disposable Virus Sampling Tubes |
Shenzhen Dakewe Bio-engineering Co., Ltd. |
Jiang Wei |
| K222910 |
04/11/2023 |
Bronchoscope System |
Shenzhen HugeMed Medical Technical Development Co., Ltd |
Cathy S |
| K230360 |
04/10/2023 |
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 |
Shenzhen Jizhimei Technology Co., Ltd. |
Guo Miaosi |
| K222548 |
04/26/2023 |
Endo Motor |
Shenzhen Perfect Medical Instruments Co., Ltd. |
Kristy Mo |
| K230122 |
04/10/2023 |
IPL Hair Removal Device, Model(s): UI04áSD, UI04áDG |
Shenzhen Ulike Smart Electronics Co.,Ltd |
Shane Xie |
| K230549 |
04/25/2023 |
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG |
Shenzhen Xiazhifeng Electronic Co., Ltd. |
James Li |
| K213749 |
04/03/2023 |
G7, Dental Operative Unit and Accessories |
Shinhung Company Ltd |
Sam Su Kyong |
| K222360 |
04/06/2023 |
AI-Rad Companion (Cardiovascular) |
Siemens Medical Solutions U.S.A. |
Alexandra Fink |
| K230402 |
04/11/2023 |
ENROUTE« Transcarotid Neuroprotection System |
Silk Road Medical |
Denise Aycox |
| K230908 |
04/28/2023 |
Hand Trauma Threaded Nail System |
Skeletal Dynamics, Inc. |
Alexandra Rodriguez Rojas |
| K223018 |
04/14/2023 |
OSPREY PERIPHERAL IV Catheter System |
SkyDance Vascular, Inc. |
Scott Pease |
| K221537 |
04/05/2023 |
Nightwear Aligners |
Smylio Inc. |
Ren Menon |
| K230103 |
04/24/2023 |
Klockner Abutments |
Soadco, S.L. |
Mercedes Roldan |
| K230820 |
04/18/2023 |
SofWave System |
Sofwave Medical Ltd |
Ruthie Amir |
| K223287 |
04/20/2023 |
Velacur |
Sonic Incytes |
Barry Allen |
| K222469 |
04/17/2023 |
TIB Abutments |
Southern Implants (Pty) Ltd |
Leith C. Cumming |
| K230600 |
04/28/2023 |
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) |
Spectrum Dynamics Medical Ltd |
Igor Naroditsky |
| K230053 |
04/19/2023 |
SimpliFix Hip System |
Stabiliz Orthopaedics Inc. |
Douglas Cerynik |
| K223141 |
04/24/2023 |
STR8 Clear Aligner |
STR8 Oral Care |
Misee Harris |
| K230754 |
04/11/2023 |
L12 LED Light Source with AIM |
Stryker |
April Malmborg |
| K222381 |
04/27/2023 |
PeriPROÖ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System |
Stryker GmbH |
Danielle Jannuzzi Madureira |
| K223772 |
04/07/2023 |
PRO Plating System, Stryker Trauma Pelvic Set (Matta) |
Stryker GMbH |
Danielle Jannuzzi Madureira |
| K223052 |
04/07/2023 |
Peri-Guard and Supple Peri-Guard |
Synovis Life Technologies, Inc. |
Megan Sajjad |
| K230058 |
04/28/2023 |
Bladeless Trocar û Artemis Lap Cannula |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K223256 |
04/05/2023 |
OptimosÖ Cystotome |
Taewoong Medical Co., Ltd. |
Yongjin Jeff Kim |
| K230480 |
04/28/2023 |
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) |
Teleflex Medical |
Hope West |
| K230412 |
04/13/2023 |
Symmed Elite Aesthetic |
TermoSalud |
Cristina Cifuentes Pantoja |
| K230143 |
04/13/2023 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K221895 |
04/18/2023 |
Terumo Advanced Perfusion System 1 |
Terumo Cardiovascular Systems Corporation |
Eileen Dorsey |
| K230023 |
04/19/2023 |
ART-Plan |
Therapanacea SAS |
Catherine Martineau-Huynh |
| K230202 |
04/25/2023 |
TMINIÖ Miniature Robotic System |
THINK Surgical, Inc. |
Meliha Mulalic |
| K222095 |
04/20/2023 |
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 |
Thrombolex, Inc. |
Amy Katsikas |
| K230749 |
04/17/2023 |
TriMed Threaded Intramedullary Nail System |
TriMed, Inc. |
David Medoff |
| K230699 |
04/10/2023 |
ARIA Radiation Therapy Management (v18.0) |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K230204 |
04/25/2023 |
ALPHALOK Plating System |
Vilex LLC |
Brock Johnson |
| K223513 |
04/18/2023 |
UniVyÖ OsteoVyÖ-Ti Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K222066 |
04/14/2023 |
LINK MobileLink Acetabular Cup System |
Waldemar Link GmbH & Co KG |
Stefanie Fuchs |
| K223139 |
04/25/2023 |
Wallaby 017 Micro Catheter |
Wallaby Medical |
Joseph Tang |
| K223862 |
04/28/2023 |
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp |
Won Tech Co., Ltd. |
Hyun Sik Yoon |
| K230090 |
04/19/2023 |
Diode Laser Hair Removal |
Wuhan Lotuxs Technology Co., Ltd. |
Na Wu |
| K223201 |
04/19/2023 |
TAP Lancet |
YourBio Health, Inc. |
Sean McCarthy |
| K213986 |
04/13/2023 |
CerebralGo Plus |
Yukun (Beijing) Technology Co., Ltd |
Wang Qi |
| K223454 |
04/17/2023 |
Custom-made Invisible Aligners |
Zhejiang Yinchili Medical Technology Co., Ltd. |
Xinyan Zhang |
