| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K232392 |
11/16/2023 |
CT Lung Ventilation Analysis Software (CT:V) |
4DMedical Limited |
Nichole Murray |
| K221266 |
01/05/2023 |
Cervical Spine Truss System (CSTS) Interbody Fusion Device |
4WEB Medical, Inc. |
Lewis Harrison |
| K230828 |
11/09/2023 |
Flowflex COVID-19 Antigen Home Test |
ACON Laboratories, Inc. |
Qiyi Xie |
| K231254 |
11/03/2023 |
GripTract-GI Endoscopic Tissue Manipulator |
Actuated Medical, Inc. |
Douglas R. Dillon |
| K230878 |
11/14/2023 |
QScout Lab; QScout RLD |
Ad Astra Diagnostics, Inc. |
Jasper Pollard |
| K213198 |
01/05/2023 |
Ax-Surgi Surgical Hemostat |
Advamedica Inc. |
Leo Mavely |
| K223719 |
01/11/2023 |
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System |
Aegis Spine, Inc. |
Kihyang Kim |
| K223521 |
01/20/2023 |
ZESPIN SI Joint Fusion System |
Aegis Spine, Inc. |
KiHyang Kim |
| K222458 |
01/12/2023 |
AIBOLIT 3D+ |
Aibolit Technologies, LLC |
Gregory Piskun |
| K231631 |
11/28/2023 |
BriefCase-Quantification |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K232083 |
11/13/2023 |
BriefCase-Quantification |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K230534 |
11/08/2023 |
BriefCase-Quantification |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K232029 |
11/02/2023 |
VersaWrap Nerve Protector |
Alafair Biosciences Inc |
Angela Mallery |
| K232921 |
11/16/2023 |
DAILIES TOTAL1«; DAILIES TOTAL1« Toric; DAILIES TOTAL1« Multifocal; DAILIES TOTAL1« Multifocal Toric |
Alcon Laboratories, Inc. |
Martina Heim |
| K223819 |
01/18/2023 |
SI-Cure Sacroiliac Joint Fusion System |
Alevio, LLC |
Trey Robbins |
| K232925 |
11/17/2023 |
Gastric Alimetry System |
Alimetry Ltd. |
Yaara Yarmut |
| K232345 |
11/02/2023 |
ATEC Posterior Navigated Disc Prep Instruments |
Alphatec Spine, Inc. |
Sandy Gill |
| K223782 |
01/12/2023 |
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set |
Ambu A/S |
Kristian Moltved |
| K230078 |
11/03/2023 |
TRAX« CR Total Knee System |
Amplitude |
Hugo Catois |
| K230061 |
11/30/2023 |
Insulin Syringe |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Bingyi Xiang |
| K222809 |
01/03/2023 |
Medical Disposable Face Masks |
Anqing Mayfield Medical Limited |
Minghan Zhou |
| K233160 |
11/25/2023 |
NeuTrace EP Mapping System v.2.1 |
Anumana, Inc |
Suzanne Goodman |
| K232880 |
11/01/2023 |
Inzii Ripstop Redeployable Retrieval System |
Applied Medical Resources Corporation |
Niharika Niranjan Mirji |
| K230669 |
11/30/2023 |
L-CathÖ Single and Dual Lumen Catheters, L-CathÖ Midline Catheters |
Argon Medical Devices |
Scott Bishop |
| K231752 |
11/09/2023 |
ARK Hydrocodone Assay |
ARK Diagnostics, Inc. |
Thomas Houts, Ph.D |
| K232973 |
11/15/2023 |
Arthrex Knee FiberTak« Button Suture Anchor |
Arthrex Inc |
Kristi Frisch |
| K232742 |
11/03/2023 |
Arthrex FiberTak Suture Anchor |
Arthrex Inc. |
Kristi Frisch |
| K213597 |
01/18/2023 |
MultiCut Solo |
Asclepion Laser Technologies GmbH |
Tom Gruender |
| K223866 |
01/25/2023 |
CarevixÖ Suction Cervical Stabilizer |
Aspivix SA |
Mauro Rinaldi |
| K222889 |
01/20/2023 |
FlowArt« Needle-Free Split Septum Valve |
Asset Medikal Tasarim San Tic As. |
Ebru Sirali |
| K222554 |
01/19/2023 |
EL CAPITAN Anterior Lumbar Interbody Fusion |
Astura Medical |
Parker Kelch |
| K231694 |
11/16/2023 |
MASADA Modular Spinal Fixation System |
Astura Medical |
Parker Kelch |
| K233407 |
11/02/2023 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion Syst |
AtriCure, Inc. |
Stephanie Hadnot |
| K221125 |
01/04/2023 |
SilentCloud |
Aureliym GmBH |
Markus Haller |
| K231473 |
11/28/2023 |
Monarch Bronchoscope |
Auris Health Inc., a Johnson and Johnson Family Company |
Somi Ekwealor |
| K221787 |
11/30/2023 |
Auxein's DHS/DCS Plate System |
Auxein Medical Private Limited |
Rahul Luthra |
| K213059 |
01/27/2023 |
Tibia and Fibula System |
Auxein Medical Private Limited |
Rahul Luthra |
| K232841 |
11/15/2023 |
Axial3D Insight |
Axial Medical Printing Limited |
Joanne Flatley |
| K233110 |
11/22/2023 |
Carnation Ambulatory Monitor |
Bardy Diagnostics, Inc. |
Ben Hornsey |
| K230954 |
11/17/2023 |
Samfilcon B Custom Contact Lens |
Bausch + Lomb, Incorporated |
Barbara Klube-Falso |
| K223016 |
01/27/2023 |
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit |
BD |
Dung Nguyen |
| K230319 |
11/24/2023 |
Passio Pump Drainage System |
Bearpac Medical |
Jay Zimmerman |
| K223503 |
01/19/2023 |
Access 25(OH) Vitamin D Total |
Beckman Coulter Inc |
Kate Oelberg |
| K232600 |
11/22/2023 |
DxFLEX Flow Cytometer; ClearLLab 10C Panels |
Beckman Coulter, Inc |
Stephanie Harlacz |
| K223405 |
01/13/2023 |
Access Testosterone |
Beckman Coulter, Inc. |
Kuljeet Kaur |
| K230493 |
11/27/2023 |
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube |
Becton Dickinson and Company |
Katherine Kenner Lemus |
| K233596 |
11/09/2023 |
VarseoSmile TriniQ |
BEGO Bremer GoldschlΣgerei Wilh. Herbst GmbH & Co. KG |
Marcel Mⁿller |
| K230587 |
11/30/2023 |
Wrist Pulse Oximeter |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K222182 |
01/04/2023 |
Radial Artery Compression Tourniquets |
Beijing Demax Medical Technology Co., Ltd. |
Anny Zhang |
| K232532 |
11/02/2023 |
Nd:Yag Laser Therapy Systems |
Beijing UNT Technology Co., Ltd. |
Qianwen Sheng |
| K233010 |
11/21/2023 |
Beagank 4T Plus |
Belega Inc. |
Masayuki Okumura |
| K223754 |
11/09/2023 |
BraveCX |
Bering Ltd |
Drozdov Ignat |
| K232266 |
11/03/2023 |
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K232240 |
11/13/2023 |
Microwave Ablation System (BD-GT) |
Betters (Suzhou)Medical Co., Ltd. |
Lei Liu |
| K232241 |
11/13/2023 |
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) |
Betters(Suzhou) Medical Co., Ltd |
Lei Liu |
| K220803 |
01/27/2023 |
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 ╡g/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 ╡g/mL), VITEK 2 AST-GP Moxifloxacin |
bioMerieux, Inc |
Cherece L. Jones |
| K231150 |
11/09/2023 |
Cardio P1 |
Bionet Co., Ltd. |
Kyungeun Park |
| K231937 |
11/13/2023 |
Foundation Dermal Regeneration Scaffold (DRS) Solo |
Bionova Medical, Inc. |
Alex Greene |
| K232977 |
11/21/2023 |
Biophotas Celluma CONTOUR |
Biophotas Inc |
Patrick Johnson |
| K223644 |
01/12/2023 |
Neuronaute with IceCap 2 & IceCap 2 Small |
Bioserenity |
Madubuike Okafor |
| K231366 |
11/09/2023 |
Neuronaute Plus |
BioSerenity SAS |
Madubuike Okafor |
| K232521 |
11/16/2023 |
ExactechGPS« Total Ankle Application |
Blue Ortho |
Matthieu Coic |
| K231012 |
11/15/2023 |
CoolSeal Trinity |
Bolder Surgical, LLC |
Nicholas Wong |
| K232633 |
11/28/2023 |
Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter |
Boston Scientific |
Lingling Guo |
| K232635 |
11/22/2023 |
IceSeed 1.5 CX 90║ Needle (H7493967433170); IceSeed 1.5 CX S 90║ Needle (H7493967233100) |
Boston Scientific |
Jake Burke |
| K233503 |
11/30/2023 |
14F iSLEEVE Introducer Set |
Boston Scientific Corporation |
Alyssa Manno |
| K231498 |
11/20/2023 |
TraumaCad Neo |
Brainlab Ltd. |
Yael Guttentag |
| K232496 |
11/21/2023 |
Brainomix 360 Triage Stroke |
Brainomix Limited |
Zsolt Szrnka |
| K230856 |
11/14/2023 |
BrainSpec CoreÖ Software |
BrainSpec, Inc |
Alexandra Zimmerman |
| K221542 |
01/13/2023 |
Galileo Vertebral Body Replacement Device |
Bright Spine |
Robert Simonson |
| K223177 |
01/20/2023 |
HighlanderÖ 014 PTA Balloon Dilatation Catheter |
C.R. Bard, Inc. |
Andrew Quach |
| K233500 |
11/30/2023 |
Benesta Tissue Removal Device |
Caldera Medical, Inc. |
Vicki Gail |
| K232988 |
11/21/2023 |
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
Paul Biggins |
| K223336 |
01/09/2023 |
Vitrea Software Package, VSTP-002A |
Canon Medical Systems Corporation |
Paul Biggins |
| K221260 |
01/06/2023 |
CSF-3 |
CardiacSense |
Benita Lanzer |
| K223842 |
01/20/2023 |
DRX - Compass |
Carestream Health, Inc. |
Jessica DeRyke |
| K231955 |
11/03/2023 |
aprevo« Digital Segmentation |
Carlsmed, Inc. |
Karen Liu |
| K223794 |
01/17/2023 |
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
CEFLA S.C. |
Lorenzo Bortolotti |
| K230726 |
11/29/2023 |
CEREGLIDE 92 Intermediate Catheter |
Cerenovus, Inc. |
Ryan Rivera |
| K231414 |
11/01/2023 |
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) |
Chalice Medical Ltd |
Stephen Horan |
| K232244 |
11/29/2023 |
Disposable Endoscope Valves System |
Changzhou Endoclean Medical Device Co., Ltd. |
Qi Wang |
| K211197 |
01/19/2023 |
Disposable Endoscopic Cutter Stapler and Cartridge |
Changzhou Waston Medical Appliance Co., Ltd |
Ning Mao |
| K221606 |
11/21/2023 |
Absorbable Cranial Flap Fixation System |
Chendu MedArt Medical Scientific Co., Ltd. |
Huaping Ran |
| K222787 |
01/09/2023 |
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P |
Chongqing Sunkingdom Medical Instrument Co., Ltd |
Shulin Guo |
| K222593 |
01/18/2023 |
TruPlan Computed Tomography (CT) Imaging Software |
Circle Cardiovascular Imaging, Inc. |
Sydney Toutant |
| K231783 |
11/14/2023 |
VitroPRO |
CIVCO Medical Instruments Co., Inc. |
James Leong |
| K222406 |
01/23/2023 |
Clarius AI |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K232257 |
11/13/2023 |
Clarius Bladder AI |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K223615 |
11/21/2023 |
Digital ClarusScope System, Digital NeuroPEN System |
Clarus Medical, LLC |
Mark F. Brown |
| K230100 |
11/03/2023 |
SCIZER (SC1-M410) |
Classys Inc |
Elin Hong |
| K233243 |
11/27/2023 |
ClearPoint System (Software Version 2.2) |
ClearPoint Neuro Inc. |
Brennan Sullivan |
| K233171 |
11/27/2023 |
PF Keep; Cad Cam Keep Block |
Clemde Sa De Cv |
Francisco Cabrera |
| K223738 |
01/11/2023 |
Alpha Control Liner System (ACLS) |
Coapt |
Blair Lock |
| K231546 |
11/30/2023 |
Somfit |
Compumedics Limited |
Michael Frischman |
| K230400 |
11/08/2023 |
Cure Catheter Closed System; Cure Dextra Closed System |
ConvaTec, Inc. |
Courtney Smith |
| K223563 |
01/25/2023 |
OsteoCNX |
Converg Engineering |
Gustavo R Prado |
| K232573 |
11/21/2023 |
INFINITIÖ Ambi Angiographic Catheter |
Cordis US Corp. |
Zheng Wang |
| K223158 |
01/23/2023 |
LigaSureÖ XP Maryland Jaw Sealer/Divider |
Covidien, llc |
Miranda Miles |
| K232546 |
11/21/2023 |
Meta G UCLA Abutment |
Cowellmedi Co., Ltd. |
Haejun Lee |
| K233049 |
11/21/2023 |
TD 200« Automated TEE Probe Disinfector with TD-12« High-Level Disinfectant with QwikCheckÖ Chemical Indicator |
CS Medical LLC |
Kendall Ashe |
| K232643 |
11/28/2023 |
Cue COVID-19 Molecular Test |
Cue Health Inc. |
Sharon Young |
| K223200 |
01/06/2023 |
Curiteva Navigation System |
Curiteva, Inc. |
Eric Linder |
| K233402 |
11/01/2023 |
Bard 3DMax Mesh |
Davol Inc., Subsidiary of C.R. Bard, Inc. |
Richard Spaziano |
| K232252 |
11/28/2023 |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) |
Dehai (Shandong) Medical Gloves, Co., Ltd. |
Max Li |
| K221494 |
01/23/2023 |
Quality Mix Blender, Oxymixer |
DEHAS Medical Systems GmbH |
Jens Mittendorf |
| K191111 |
01/11/2023 |
DD Solid Connect« CAD/CAM Abutments |
Dental Direkt GmbH |
Gerhard de Boer |
| K233053 |
11/21/2023 |
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor |
Dental Imaging Technologies Corporation |
Anuradha Moholkar |
| K222976 |
01/12/2023 |
MU System |
Dentis Co., Ltd |
Gyu Ri Kim |
| K222913 |
01/13/2023 |
s-Clean Link Abutment |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K222296 |
01/06/2023 |
ARTICUL/EZE Ceramic Heads |
Depuy Ireland UC |
Paige Myers |
| K230831 |
11/13/2023 |
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid |
Depuy Ireland UC |
Yayoi Fujimaki |
| K223931 |
01/11/2023 |
Dexcom G6 Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Brittney Shaver |
| K230379 |
11/27/2023 |
Portable (Ultrasonic) Nebulizer |
Dongguan SIMZO Electronic Technology Co.Ltd. |
Jack Jin |
| K221150 |
01/25/2023 |
Advanced Bone Plate |
Double Medical Technology Inc. |
Yan Zuo |
| K221088 |
01/18/2023 |
Anatomic Bone Plate |
Double Medical Technology Inc. |
Yan Zuo |
| K221090 |
01/10/2023 |
Metal Cannulated Screw |
Double Medical Technology Inc. |
Yan Zuo |
| K233078 |
11/22/2023 |
Posterior Cervical Spine System |
Double Medical Technology Inc. |
Yan Zuo |
| K232753 |
11/16/2023 |
EXPD 4343D; EXPD 3643D |
DRTECH Corporation |
Kim Minjeong |
| K220073 |
01/26/2023 |
RMF-2000 |
DRTECH Corporation |
Suyeon Back |
| K231277 |
11/09/2023 |
TissueStat |
DuraStat LLC |
Adam Azzara |
| K223221 |
01/13/2023 |
Non-Sterile Powder Free Nitrile Examination Gloves |
Dynacare Sdn Bhd |
Chow Choong Keong |
| K230612 |
11/17/2023 |
Edwards Algorithm for Measurement of Blood Hemoglobin |
Edwards Lifesciences, LLC |
Kshama Pai |
| K232974 |
11/17/2023 |
EKGenius Smart System |
EKGenius LLC |
Shachar Barel |
| K222221 |
01/04/2023 |
DEKA HELIX |
El.En Electronic Engineering Spa |
Paolo Peruzzi |
| K230883 |
11/28/2023 |
VersaPump Infusion System |
EMED Technologies Corporation |
Olena Whalen |
| K222832 |
01/21/2023 |
Sentimag System |
Endomagnetics Ltd |
Mehryar Behizad |
| K231586 |
11/03/2023 |
Endophys Blood Pressure Monitor model BPM-30 |
Endophys Technologies LLC |
Zachary Sowell |
| K221873 |
01/12/2023 |
NeoGen PSR System |
Energist Limited |
Graham Booth |
| K223671 |
01/05/2023 |
CONDUIT LLIF Straight Inserters |
Enztec Limited |
James Sheat |
| K230343 |
11/03/2023 |
ProSealÖ Closed System Administration Set |
Epic Medical Pte Ltd |
Freddie Lee |
| K232033 |
11/29/2023 |
HYBRIDknife« flex |
Erbe Elektromedizin GmbH |
Matthias Kollek |
| K230179 |
11/29/2023 |
6440 MyLabX90 |
Esaote S.p.A. |
Alberto Carcagni |
| K213423 |
01/06/2023 |
T3 Platform software |
Etiometry. Inc. |
Tim Hanson |
| K230481 |
11/03/2023 |
Evenflo Premium Double Electric Breast Pump (Model 4018) |
Evenflo Feeding, Inc. |
Michael Sewak |
| K232501 |
11/17/2023 |
AI Platform (AIP001) |
Exo Inc |
Jacqueline Murray |
| K230700 |
11/20/2023 |
RIWOtrack Navigation System |
Fiagon GmbH |
Dirk Mucha |
| K232545 |
11/20/2023 |
The SensiTox B. anthracis Toxin Test |
First Light Diagnostics, Inc. |
Joanne Spadoro |
| K221338 |
01/27/2023 |
F&P Airvo 3 |
Fisher & Paykel Healthcare |
Reena Daken |
| K222712 |
11/22/2023 |
Fogg System Patient Monitoring Cables |
Fogg System Company, Inc. |
Ken Neef |
| K223540 |
01/19/2023 |
AvalancheLase Family |
Fotona d.o.o. |
Tina Bartolic |
| K222845 |
11/28/2023 |
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece |
Frey Oral Technologies LLC |
David Frey |
| K223295 |
01/11/2023 |
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D |
FUJIFILM Corporaton |
Randy Vader |
| K221551 |
01/27/2023 |
FUJIFILM Endoscope Model EI-740D/S |
FUJIFILM Corporaton |
Randy Vader |
| K231941 |
11/20/2023 |
ARIETTA x10 |
Fujifilm Healthcare Americas Corporation |
Chaitrali Kulkarni |
| K221619 |
01/26/2023 |
ECHELON Oval V6.2 MRI System |
Fujifilm Healthcare Corporation |
Randy Vader |
| K231804 |
11/09/2023 |
PRIME-XV FreezIS DMSO-Free MD |
Fujifilm Irvine Scientific |
Amanda Cinquin |
| K221774 |
01/12/2023 |
Garmin ECG App |
Garmin International, Inc. |
Travis Johnson |
| K232292 |
11/07/2023 |
Peridot-EX Expandable Intervertebral Body Fusion System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K233084 |
11/21/2023 |
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K223378 |
01/03/2023 |
3.0T 16ch AIR AA |
GE Healthcare Coils (USA Instruments, Inc.) |
Lauren Ross |
| K232186 |
11/03/2023 |
LOGIQ e |
GE Medical Systems Ultrasound and Primary Care Diagnostic, |
Lee Bush |
| K231989 |
11/07/2023 |
LOGIQ E10s, LOGIQ Fortis |
GE Medical Systems Ultrasound and Primary Care Diagnostic, |
Bryan Behn |
| K231966 |
11/07/2023 |
LOGIQ E10 |
GE Medical Systems Ultrasound and Primary care Diagnostics, |
Bryan Behn |
| K233200 |
11/16/2023 |
XPLUS 35 Series (XPLUS 35, XPLUS 35FD) |
Gemss Healthcare Co., Ltd. |
Jiho Park |
| K230800 |
11/02/2023 |
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 |
Gemss Healthcare Co., Ltd. |
Jiho Park |
| K223847 |
01/25/2023 |
CREEDÖ Cannulated Screws |
GLW, Inc. |
Arundhati Radhakrishnan |
| K221419 |
01/20/2023 |
TD-5010 Lancing Device and TD-5084 Sterile Lancets |
GOSTAR Co., Ltd. |
Pei-Fen Yang |
| K232059 |
11/24/2023 |
Tympanostomy Tubes |
Grace Medical, Inc. |
Mark Melton |
| K233502 |
11/01/2023 |
TERA HARZ II |
Graphy Inc. |
Moon Soo Park |
| K231250 |
11/28/2023 |
Digital Blood Pressure Monitor |
Guangdong Genial Technology Co., Ltd. |
Yu Jun |
| K231245 |
11/22/2023 |
Digital Blood Pressure Monitor (Arm Type) |
Guangdong Genial Technology Co., Ltd. |
Yu Jun |
| K231155 |
11/07/2023 |
Biodegradable Medical surgical mask |
Guangdong Kingfa Sci. & Tech. Co., Ltd. |
Xiaoge Yu |
| K232713 |
11/28/2023 |
Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Jerry Fan |
| K232621 |
11/22/2023 |
Blood pressure monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Jerry Fan |
| K214077 |
01/20/2023 |
Digital Thermometer, Model: DT007, DT008 |
Guangzhou Berrcom Medical Device Co., Ltd. |
Zhigang Du |
| K233428 |
11/03/2023 |
Easycess Aspiration Pump |
Guangzhou Easycess Medical Co., Ltd |
Xingcheng Liu |
| K222403 |
01/26/2023 |
Surgical Gown |
Guangzhou Fuzelong Hygiene Material Co., Ltd |
Yuehua Zhou |
| K233056 |
11/02/2023 |
EpiZact |
GuideStar Medical Devices |
Michael Dolphin |
| K223414 |
11/15/2023 |
Curing Light, Model: MaxCure 9 |
Guilin Refine Medical Instrument Co., Ltd. |
Chen Judong |
| K230641 |
11/21/2023 |
Ultrasonic Scaler Tips |
Guilin Refine Medical Instrument Co., Ltd. |
Chen Judong |
| K221306 |
01/27/2023 |
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories |
Gyrus ACMI, Inc. |
Jon Gilber |
| K233518 |
11/02/2023 |
BASE290 LED Curing Light |
Handpiece Headquarters |
Frederick Wang |
| K222170 |
01/13/2023 |
Power Acute Triple Lumen Hemodialysis Catheter |
Health Line International Corporation |
Aaron G Faulkner |
| K232886 |
11/08/2023 |
INFILOOP« Fixed Loop UHMWPE Suture Titanium Button |
Healthium Medtech Limited |
Pankaj Dawar |
| K232709 |
11/30/2023 |
Diode laser therapy device |
Hebei Zhemai Technology Co., Ltd |
Yuting Qu |
| K232716 |
11/30/2023 |
Q-Switched Nd:Yag laser |
Hebei Zhemai Technology Co., Ltd |
Yuting Qu |
| K233346 |
11/20/2023 |
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 |
11/20/2023 |
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 |
| K213655 |
01/17/2023 |
HiTop« (Models: HiToP«4touch, HiToP«2touch, HiToP«1touch) |
HillTek LLC |
Mohammadali Nezakati |
| K231316 |
11/06/2023 |
Aptima Trichomonas vaginalis Assay |
Hologic, Inc. |
Jingwen Chen |
| K230451 |
11/16/2023 |
Aptima« Chlamydia trachomatis Assay |
Hologic, Inc. |
Jon Kukowski |
| K214078 |
01/13/2023 |
SilkÆn Toothwave |
Home Skinovations Ltd. |
Amit Goren |
| K221278 |
01/11/2023 |
Transducer Probe Cover |
Hony Medical Co., Ltd. |
Zhu Huina |
| K223528 |
01/20/2023 |
Triathlon« Hinge Knee System |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
Allison Byrne |
| K222056 |
01/26/2023 |
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Margaret Klippel |
| K223314 |
01/25/2023 |
Disposable Blood Lancets |
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD |
Zhengcan Da |
| K223313 |
01/23/2023 |
Disposable Safety Lancets |
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD |
Zhengcan Da |
| K222483 |
01/04/2023 |
Surgical Face Mask |
Hubei Woozon Healthcare Co.,Ltd. |
Li Chunlin |
| K230475 |
11/03/2023 |
Medical Video Endoscope System |
HUGER Medical Instrument Co., Ltd. |
Lei Lu |
| K222011 |
01/12/2023 |
HandX Instrument - Monopolar Spatula |
Human Xtensions Ltd. |
Maija Wallenstein |
| K222181 |
01/11/2023 |
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate |
Iconic medicare sdn bhd |
Tan Cho Chia |
| K222789 |
01/09/2023 |
VADER« Pedicle System, G21 Cement |
icotec ag |
Marina Hess |
| K213263 |
01/04/2023 |
OnyxCeph |
Image Instruments GmbH |
Greg Holland |
| K232898 |
11/21/2023 |
QuantisalÖ Oral Fluid Collection Device |
Immunalysis Corporation |
Shubhajit Mitra |
| K223000 |
01/11/2023 |
Artix BG |
Inari Medical |
Ellen Nguyen |
| K232139 |
11/16/2023 |
Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens |
Innova Vision Inc. |
Celine Hsu |
| K223254 |
01/27/2023 |
C2 Xplore |
Inomed Medizintechnik GmbH |
Maximilian Wimmer |
| K232730 |
11/01/2023 |
Aventus Thrombectomy System |
Inquis Medical |
Mojgan Saadat |
| K223090 |
01/27/2023 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co |
Gabriella Erdosy |
| K222589 |
01/26/2023 |
Flexible Suturing System with Anchors (FSSA) |
Integrity Orthopaedics, Inc. |
Jeff Sims |
| K231798 |
11/08/2023 |
da Vinci SP Surgical System |
Intuitive Surgical, Inc. |
Connor McCarty |
| K232028 |
11/17/2023 |
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) |
IQ Endoscopes Limited |
Chris Jenkins |
| K223010 |
01/17/2023 |
Portable X-ray System |
iRay Technology Taicang Ltd. |
Wei Pan |
| K223675 |
01/06/2023 |
WatchPAT ONE (WP1) |
Itamar Medical, LTD |
Efrat Litman |
| K222462 |
01/20/2023 |
Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-au |
ITP Innovative Tomography Products GmbH |
Dr. Heinz-Werner Henke |
| K223685 |
01/04/2023 |
SmoothCool HR System |
Jeisys Medical Inc |
Sang Hoon Hwang |
| K222834 |
01/05/2023 |
Safety Push Button Blood Collection Set |
Jiangsu Caina Medical Co.,Ltd |
Jianwei Pan |
| K232866 |
11/07/2023 |
Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) |
Jiangsu Channel Medical Device Co., Ltd |
Eric Huang |
| K232576 |
11/21/2023 |
Medical Nitrile Examination Gloves |
Jiangsu Complete Sincerity Medical New Materials Co., Ltd. |
Shangjun Xie |
| K230969 |
11/09/2023 |
Oxygen Concentrator |
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. |
Yu Yao |
| K221682 |
01/13/2023 |
Ideal Med Pro 3-Ply Disposable Face Mask |
JSN Holdings, LLC |
Brian Tedesco |
| K233332 |
11/27/2023 |
Statera-CÖ Spinal System |
K&J Consulting Corp. |
Milan George |
| K222158 |
01/20/2023 |
Capiflo 5001 |
K&L Distributing, Inc. |
Mark Julian |
| K232857 |
11/06/2023 |
KARL STORZ ICG Imaging System |
Karl Storz SE & Co. Kg |
Alita McElroy |
| K233333 |
11/21/2023 |
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit |
KARL STORZ SE & CO. KG |
Emily Rhiel |
| K232593 |
11/22/2023 |
FITme Customized Silicone Implant |
Keosan Trading Co. |
Priscilla Chung |
| K222830 |
01/12/2023 |
Rainbow 360 |
Kerr Corporation |
Viviana Lai |
| K223927 |
01/27/2023 |
360CAS |
Kico Knee Innovation Company Pty Limited |
Danyon Munro |
| K223749 |
01/06/2023 |
U by Kotex« Click« Unscented Menstrual Tampons |
Kimberly-Clark Corporation |
Jeremy Paulsen |
| K230211 |
11/21/2023 |
CranioXpand |
KLS-Martin L.P. |
Melissa Bachorski |
| K231918 |
11/03/2023 |
Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter |
Koru Medical Systems |
Emily DiMambro |
| K232461 |
11/14/2023 |
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; |
Kossan International Sdn Bhd |
Cho Sow Fong |
| K233245 |
11/21/2023 |
MagnetOs Flex Matrix |
Kuros Biosciences B.V. |
Hen Baron |
| K223474 |
01/13/2023 |
PathLoc-TA Expandable Lumbar Cage System |
L&K Biomed Co., Ltd. |
Katherine Kim |
| K223588 |
01/26/2023 |
PALLAS Premium |
Laseroptek Co., Ltd. |
Hong Chu |
| DEN200070 |
11/15/2023 |
Simple 2 Test |
LetsGetChecked Inc. (formerly PrivaPath Diagnostics Inc.) |
Karen Walsh |
| K223546 |
01/27/2023 |
14HQ721G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K223789 |
01/09/2023 |
21HQ513D |
LG Electronics Inc. |
Jinhwan Jun |
| K232611 |
11/30/2023 |
TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System |
Life Spine, Inc. |
Angela Batker |
| K222780 |
11/09/2023 |
LILY Extension Tube and Needleless Connector |
LILY Medical Corporation |
Steven Shen |
| K231877 |
11/30/2023 |
NavaClick Injection System |
Lineage Biomedical, Inc. |
Bradley Pliskow |
| K213772 |
01/19/2023 |
LM-9300 Plus Lithotripter |
Lite-Med Inc. |
Walt Hsu |
| K231920 |
11/09/2023 |
Longeviti ClearFit OTS Cranial Implant |
Longeviti Neuro Solutions, LLC |
Jesse Christopher |
| K232076 |
11/02/2023 |
Fibercure |
Lumendo AG |
Mark Bispinghoff |
| K231470 |
11/06/2023 |
Lunit INSIGHT DBT |
Lunit Inc. |
Hyung Tak Han |
| K231818 |
11/15/2023 |
METICÖ- Airway Balloon Catheter |
M/s Meril Life Sciences Pvt. Ltd. |
Umesh Sharma |
| K231393 |
11/30/2023 |
Radical the Dude 7F Guide Catheter |
Maduro Medical, Inc. |
Janice Kemp |
| K222171 |
01/13/2023 |
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ |
Magstim Company Ltd |
Tom Campbell |
| K223415 |
01/26/2023 |
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Mah Sing Healthcare Sdn Bhd |
Ivan Tan Chee Wei |
| K231569 |
11/03/2023 |
ManaFlexx 2 (model: MF002-RX, MF002-OTC) |
ManaMed, Inc |
Trevor Theriot |
| K232512 |
11/17/2023 |
Masimo W1 |
Masimo Corporation |
Sindura Penubarthi |
| K233408 |
11/09/2023 |
Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner |
Materialise N.V. |
Giulia Girola |
| K230529 |
11/22/2023 |
HealiAid Dental Collagen Wound Dressing |
Maxigen Biotech Inc. |
Cheng-Han Zhou |
| K221725 |
01/20/2023 |
Advanced MyHip Planner |
Medacta International S.A. |
Stefano Baj |
| K223795 |
01/17/2023 |
FairFix QT Adjustable Button |
Medacta International S.A. |
Stefano Baj |
| K231911 |
11/09/2023 |
Glenoid Reconstruction System û Full Wedge Baseplate |
Medacta International S.A. |
Stefano Baj |
| K223548 |
01/20/2023 |
GMK Sphere & GMK SpheriKA Cementless |
Medacta International S.A. |
Stefano Baj |
| K223166 |
01/19/2023 |
Medaica M1 Telehealth Stethoscope |
Medaica Inc. |
Stephen Randall |
| K232251 |
11/03/2023 |
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension |
Medartis AG |
Claudia De Santis |
| K212684 |
01/28/2023 |
BrainView QEEG Software |
Medeia, Inc. |
Slav Danev |
| K232222 |
11/27/2023 |
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) |
Medency S.r.l. |
Alessandro Zorgati |
| K211559 |
01/27/2023 |
EasyStat 300 |
Medica Corporation |
Photios Makris |
| K232945 |
11/16/2023 |
Trio-CT¡« Triple Lumen Catheter w/ Curved Extensions |
Medical Components Inc. (Dba MedComp) |
Danielle McKinney |
| K222000 |
01/18/2023 |
Transit-Pellets |
Medifactia AB |
Diana Nystrom |
| K231797 |
11/22/2023 |
Medifun Lancing Device, Model No. LD-E1 |
Medifun Corporation |
Aaron Chen |
| K223739 |
11/08/2023 |
VS Tabletop Tonometer |
Medimaging Integrated Solution Inc |
Joanne Wang |
| K231661 |
11/27/2023 |
CryoThinÖ Surgical System and Accessories |
Medinux (Tianjin) Technologies Co., Ltd. |
Diana Zhang |
| K223480 |
01/13/2023 |
Medipoint Blood Lancets |
Medipoint Holdings, LLC |
Rochelle Stern |
| K210166 |
01/27/2023 |
Omnispec ED1000 |
Medispec Ltd. |
Avner Spector |
| K222665 |
01/25/2023 |
Medline UNITE« Ankle Fusion Plating System |
Medline Industries, Inc. |
Jennifer Mason |
| K233366 |
11/09/2023 |
SYMPHONY OCT System |
Medos International SARL |
Sheree Geller |
| K223108 |
01/19/2023 |
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) |
Medos International, SARL |
Karin McDonough |
| K230589 |
11/17/2023 |
Celox Rapid X-Ray Gauze |
Medtrade Products Ltd. |
Kelsey Gomes |
| K223494 |
01/23/2023 |
CD Horizon Spinal System |
Medtronic |
Madhuvanthi Soundirarajan |
| K223764 |
01/11/2023 |
INFINITY OCT System |
Medtronic Sofamor Danek USA, Inc. |
Laura Beth Parr |
| K211812 |
01/06/2023 |
BLUEDIAMOND IMPLANT, Abutment Screw |
MegaGen Implant Co., Ltd. |
Hyo Eun Lee |
| K222779 |
01/26/2023 |
Revogene |
Meridian Bioscience, Inc |
Jack Rogers |
| K223872 |
01/19/2023 |
Low Profile Companion Sheath |
Merit Medical Systems, Inc. |
Kirk McIntosh |
| K233525 |
11/24/2023 |
MF SC Facial Toning System |
Micro Current Technology, Inc. |
David Suzuki |
| K233420 |
11/07/2023 |
Axium Detachable Coil; Axium Prime Detachable Coil |
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular |
Lekshmi Ajaykumar Pillai |
| K232810 |
11/09/2023 |
Dental Handpiece, Wireless Endodontic Handpiece, endoit |
Micro-NX Co., Ltd. |
Haim Yoon |
| K231020 |
11/17/2023 |
Alinity c Tricyclic Antidepressants Reagent Kit |
Microgenics Corporation |
Pranjali Shinde |
| K222115 |
01/10/2023 |
ISAAC Neurovascular Navigation Catheter |
MicroVention, Inc. |
Sona Manickam |
| K231765 |
11/08/2023 |
Contour ProtΘgΘAI |
MIM Software Inc. |
Lynn Hanigan |
| K223800 |
01/17/2023 |
MIM û Additional Tracers |
MIM Software Inc. |
Megan Fontanez |
| K223107 |
01/18/2023 |
MOLLI 2 |
MOLLI Surgical, Inc |
Joseph De Croos |
| K231203 |
11/29/2023 |
Mosie Baby Kit |
Mosie Baby |
Maureen Brown |
| K223351 |
01/31/2023 |
Naviswiss Knee |
Naviswiss AG |
Domenico Romeo |
| K223222 |
01/17/2023 |
Plasma IQ |
Neauvia North America, Inc |
Joy Willard |
| K231738 |
11/16/2023 |
NEUWAVEÖ Microwave Ablation System and Accessories |
NeuWave Medical, Inc. |
Mohamed Shariff |
| K221424 |
01/26/2023 |
Sterile Surgical Powder Free Latex Glove |
New Era Medicare Sdn. Bhd. |
Fatin Nor Irdina binti Ahmad Fauzi |
| K232388 |
11/21/2023 |
High Pressure Tubing |
Ningbo DIZEGENS Medical Science Co., Ltd. |
Zhang Wenwei |
| K213175 |
01/19/2023 |
No Stress Impress |
No Stress Impress LLC |
Misael Otero |
| K232001 |
11/21/2023 |
Nu Skin RenuSpa iO |
NSE Products, Inc |
McKay Noll |
| K230463 |
11/15/2023 |
NSite Scoliosis Assessment App |
NSite, Inc. |
Michael J. Gardner |
| K223731 |
01/12/2023 |
NuVasive Modulus-C Interbody System |
Nuvasive, Inc. |
Meet Vaghani |
| K223181 |
01/11/2023 |
NuVasive Reline System |
NuVasive, Incorporated |
Bland Tanesha |
| K233343 |
11/27/2023 |
SteriCap Safety Needle; VitreJect Safety Needle |
OcuJect, LLC |
Leonid Lerner |
| K231600 |
11/17/2023 |
SENDERO Microcatheter |
Okami Medical, Inc. |
Jill Delsman |
| K223502 |
01/13/2023 |
MR Diffusion Perfusion Mismatch V1.0 |
Olea Medical |
Nathalie Palumbo |
| K221683 |
01/20/2023 |
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) |
Olympus Medical Systems Corporation |
Shinichiro Kawachi |
| K221522 |
01/19/2023 |
HF-cables (resusable) |
Olympus Winter & Ibe Gmbh |
Lilly Omland |
| K223183 |
01/13/2023 |
Light-Guide Cables |
Olympus Winter & Ibe GmbH |
Ali Sayad |
| K223348 |
01/30/2023 |
My3D« Personalized Pelvic Reconstruction |
Onkos Surgical, Inc. |
Matthew Vernak |
| K222799 |
01/10/2023 |
Haymaker« Screw System |
OrthoCircle Spine d.b.a. OC Medical Devices |
Jack Matthews |
| K221933 |
01/13/2023 |
MONTAGE Settable, Resorbable Bone Putty |
Orthocon, Inc. |
Aniq Darr |
| K223118 |
01/21/2023 |
OIC Variable Angle Small Fragment Locking Plate System |
Orthopaedic Implant Company |
Douglas Fulton |
| K232533 |
11/16/2023 |
ROSA Partial Knee System |
Orthosoft d/b/a Zimmer CAS |
Rakhi Toravane |
| K233302 |
11/16/2023 |
OSSIOfiber« Compression Staple |
Ossio Ltd. |
Taly Lindner |
| K232012 |
11/28/2023 |
N1 |
Osstem Implant Co., Ltd. |
Jimin Hyun |
| K231443 |
11/21/2023 |
Mini-OSTEO Pedicle Fixation System |
OSTEOMED Ind·stria e ComΘrcio de Implantes LTDA |
Fernando Argenton Neto |
| K223650 |
01/05/2023 |
REMEDY Stemmed Knee Spacer |
OsteoRemedies, LLC |
Eric Stookey |
| DEN220091 |
11/08/2023 |
Dream Sock |
Owlet Baby Care, Inc. |
Jim Fidacaro |
| K230701 |
11/24/2023 |
Stim2Go |
PAJUNK GmbH Medizintechnologie |
Christian Quass |
| K222901 |
01/27/2023 |
EVA15 insufflator |
Palliare Ltd. |
John O'Dea |
| K231852 |
11/15/2023 |
BinkieRT |
Papricalab |
Sohyeon Woo |
| K221949 |
01/26/2023 |
Ortho Device, ADAPTIX 3D Orthopedic Imaging System |
Pausch Medical GmbH |
Christian Stoian |
| K222848 |
01/20/2023 |
pRESET Thrombectomy Device |
phenox Limited |
Catriona Lynch |
| K230604 |
11/22/2023 |
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) |
Philips Medizin Systeme Boeblingen GmbH |
Monica Da Silva |
| K233545 |
11/30/2023 |
EPIQ Series Diagnostic Ultrasound System |
Philips Ultrasound LLC |
Michael Chambers |
| K223804 |
01/18/2023 |
PercuNav Image Fusion and Interventional Navigation System |
Philips Ultrasound LLC |
Courtney Nix |
| K203792 |
01/20/2023 |
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle |
Pikdare S.p.A |
Roberta Zanoni |
| K222567 |
01/30/2023 |
Playground For All Love Sesh |
Playground For All |
Sandy Vukovic |
| K210112 |
01/30/2023 |
XChange Device, XChange System |
Pneuma Therapeutics, Inc. |
William Densel |
| K232176 |
11/02/2023 |
STELLAR Knee |
PolarisAR Inc. |
Paul Mikus |
| K221020 |
01/13/2023 |
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F |
Potrero Medical, Inc. |
Priscila Tapia |
| K232719 |
11/21/2023 |
ProMIS Extension Rod System |
Premia Spine Ltd. |
Dorit Winitz |
| K232656 |
11/14/2023 |
BLU TOTALE (Model: ENEOB852) |
Premier North America Inc. |
Ellis Tamari |
| K222150 |
01/12/2023 |
PreXion3D Expedition |
PreXion Corporation |
Hiroaki Takahashi |
| K233434 |
11/14/2023 |
Silent Nite« Sleep Appliance with the Glidewell HingeÖ (SNGLHG) |
Prismatik Dentalcraft, Inc |
Jiahe Li |
| K231097 |
11/14/2023 |
Inclusive« Titanium Abutments compatible with: Neoss« ProActive« Narrow, Neoss« ProActive« Standard, MIS« SEVEN«, Zimmer« Eztetic« Implant Systems |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
| K223429 |
01/13/2023 |
Contour Knee |
Quality Electrodynamics, LLC |
Eric Yeh |
| K221868 |
01/27/2023 |
QOCA image Smart CXR Image Processing System |
Quanta Computer Inc. |
Joe Wang |
| K223404 |
01/20/2023 |
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V |
Quanta System, S.p.A. |
Dario Bandiera |
| K231773 |
11/08/2023 |
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with |
Qura S.r.l. |
Raffaella Tommasini |
| K223465 |
01/11/2023 |
RadianceTx Radionuclide Brachytherapy Source |
Radiance Therapeutics Inc. |
Laurence Marsteller |
| K220649 |
01/17/2023 |
Elucis |
Realize Medical Inc. |
Dan La Russa |
| K231865 |
11/06/2023 |
Mouth Guard (ATG0603R) |
Reazeal Corp |
Liu Fuhua |
| K233493 |
11/28/2023 |
Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Sha |
Relign Corporation |
Nathan Nguyen |
| K232595 |
11/28/2023 |
Kinos Axiom Total Ankle System |
restor3d |
Brianna Prindle |
| K231519 |
11/06/2023 |
Revital Cady |
Revital Healthcare (EPZ) Limited |
Ankur Vora |
| K233468 |
11/14/2023 |
Iconix Anchor |
Riverpoint Medical |
Bianca Silva de Sousa |
| K233552 |
11/30/2023 |
IDEAL Ziploop |
Riverpoint Medical |
Becca DeFrancia |
| K222907 |
01/04/2023 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
RMKH Glove (Cambodia) Co., Ltd. |
Yang Clement KC |
| K232488 |
11/13/2023 |
Accu-Chek Safe-T-Pro Plus Lancing Device |
Roche Diabetes Care, Inc. |
Kacia Mills |
| K232509 |
11/13/2023 |
Accu-Chek Safe-T-Pro Uno Lancing Device |
Roche Diabetes Care, Inc. |
Kacia Mills |
| K221693 |
01/04/2023 |
Elecsys Anti-HCV II (08837031190) |
Roche Diagnostics |
Bin Sun |
| K230190 |
11/17/2023 |
Polyver Silver Alginate Dressing (Prescription and OTC) |
Roosin Medical Co., Ltd. |
Dayong Chen |
| K232050 |
11/14/2023 |
saremco print BRIDGETEC |
Saremco Dental AG |
Franca Schmid |
| K222801 |
01/25/2023 |
Safety Lancet |
Sarstedt AG & CO KG |
Jochen Hoffman |
| K222437 |
01/26/2023 |
Aristotle Colossus Guidewire |
Scientia Vascular Inc |
Max Alfonso |
| K231521 |
11/14/2023 |
Broncho Videoscope System |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K221252 |
01/13/2023 |
Scivita 4KINSIGHT ICG Imaging System |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K233414 |
11/28/2023 |
Shoreline ACS Interbody System; Shoreline RT Interbody System |
SeaSpine Orthopedics Corporation |
Kendal Moulton |
| K211759 |
01/18/2023 |
Selux AST System; Model AST Gen 1.0 |
Selux Diagnostics, Inc. |
Eric Stern |
| K223903 |
01/27/2023 |
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) |
Semperit Investments Asia PTE LTD. |
Alexander Weinert |
| K203380 |
01/06/2023 |
Disposable Surgical Face Mask |
Shandong Pop Jeans Intelligent Manufacturing Co., Ltd. |
Wang Jing |
| K203833 |
01/27/2023 |
Tacrolimus Assay Kit |
Shanghai Genext Medical Technology Co., Ltd. |
Kimmy Zong |
| K232069 |
11/29/2023 |
Expandable Lumbar Fusion Cage (Type I,Type II) |
Shanghai REACH Medical Instrument Co., Ltd. |
Jian Shen |
| K222499 |
11/22/2023 |
Disposable Endoscope Valves Kit |
Shanghai SeeGen Photoelectric Technology Co., Ltd. |
Yihua Ma |
| K231482 |
11/29/2023 |
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K220059 |
01/19/2023 |
BiosciÖ Inactivated Transport Medium, BiosciÖ ITM |
Shenzhen Dakewe Bio-engineering Co., Ltd. |
Wei Jiang |
| K231118 |
11/13/2023 |
Cystoscope System |
Shenzhen HugeMed Medical Technical Development Co., Ltd. |
Jiang Yuanning |
| K232575 |
11/20/2023 |
Hair Removal Device, Model(s): R2815-G Pro, R2815-G |
Shenzhen Jianchao Intelligent Technology Co., Ltd. |
Fred Li |
| K220448 |
01/19/2023 |
Disposable Non-invasive EEG Sensor |
Shenzhen Med-link Electronics Tech Co., Ltd. |
Yi Liu |
| K232772 |
11/29/2023 |
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 |
| K231440 |
11/03/2023 |
Combo Electrotherapy Device |
Shenzhen Roundwhale Technology Co., Ltd. |
Zeng Chunming |
| K222252 |
01/19/2023 |
Self-adhesive Electrode |
Shenzhen Roundwhale Technology Co., Ltd. |
Zeng Chunming |
| K232845 |
11/14/2023 |
IPL Cooling Hair Removal Device |
Shenzhen Siken 3D Technology Development Co., Ltd. |
Jingquan Liu |
| K222045 |
01/04/2023 |
Wearable Breast Pump (Model S1DW) |
Shenzhen TPH Technology Co.,Ltd. |
Peter Chen |
| K221317 |
01/13/2023 |
S-Mono |
Shinhung MST Co., Ltd. |
Sun Ho Lee |
| K232624 |
11/27/2023 |
CardioPhase« hsCRP |
Siemens Healthcare Diagnostic Products GmbH |
Petra Dissmann |
| K233532 |
11/29/2023 |
MULTIX Impact E |
Siemens Medical Solutions |
Camila Rodriguez Valentin |
| K223363 |
01/12/2023 |
MAMMOVISTA B.smart (VB70) |
Siemens Medical Solutions USA Inc. |
Denise Adams |
| K232494 |
11/14/2023 |
MAGNETOM Avanto fit; MAGNETOM Skyra fit |
Siemens Medical Solutions USA, Inc. |
Milind Dhamankar |
| K231617 |
11/09/2023 |
MAGNETOM Free.Max; MAGNETOM Free.Star |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K232000 |
11/28/2023 |
syngo.via MI Workflows; Scenium; syngo MBF |
Siemens Medical Solutions USA, Inc. |
Clayton Ginn |
| K232155 |
11/30/2023 |
syngo.CT Dual Energy |
Siemens Medical Solutions, USA, Inc. |
Monsuru K. Bello |
| K223635 |
01/04/2023 |
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer |
Sienco, Inc. |
Jennifer Aiken |
| K220495 |
01/13/2023 |
SignaSure Dual Mobility System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K223446 |
01/18/2023 |
eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) |
Signifier Medical Technologies Ltd |
Yasser Zayni |
| K222664 |
01/27/2023 |
Sim&Size |
Sim&Cure |
Colette Maurin |
| K230849 |
11/13/2023 |
ELLAVI UBT |
SINAPI Biomedical (Pty) Ltd. |
Chris de Villiers |
| K223682 |
11/09/2023 |
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit |
Sirius Medical Systems B.V. |
Bram Schermers |
| K220847 |
01/03/2023 |
AETOS Shoulder System |
Smith & Nephew, Inc. |
Cassidy Lemkau |
| K220884 |
01/17/2023 |
Disposable Endoscope Valve Sets |
SML Med-Tech Solutions Limited |
Mark Ko |
| K232549 |
11/21/2023 |
NemoCast |
Software Nemotec S.L. |
Miguel del Moral |
| K231104 |
11/27/2023 |
ABPMpro |
SOMNOmedics GmbH |
Timo Gehring |
| K231652 |
11/16/2023 |
D100 KIDS; D101 KIDS |
Sorin Group Italia S.R.L. |
Luigi Vecchi |
| K223775 |
01/03/2023 |
EZ-STIK Electrodes |
South Dakota Partners |
Mike Plunkett |
| K222511 |
11/21/2023 |
Oxy2Pro |
Southmedic Inc. |
Christine Puddicombe |
| K213514 |
01/13/2023 |
Spectricept Skin and Wound Cleanser |
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. |
Hoji Alimi |
| K233191 |
11/21/2023 |
TotalTi ACDF by SAGICO |
Spinal Analytics & Geometrical Implant Co, LLC |
James J. Gibson |
| K233527 |
11/29/2023 |
Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate |
Spinal Simplicity LLC |
Adam Rogers |
| K230927 |
11/01/2023 |
OptiMesh Multiplanar Expandable Interbody Fusion System |
Spineology Inc. |
Andrew Adams |
| K231724 |
11/09/2023 |
Flush Syringe (Prefilled 0.9% normal saline solution) |
SPM Medicare Pvt. Ltd. |
Sanjay Kumar |
| K223306 |
01/25/2023 |
SPRINT Peripheral Nerve Stimulation (PNS) System |
SPR Therapeutics, Inc. |
Kathryn Stager |
| DEN220090 |
11/06/2023 |
EasySepÖ Human Bone Marrow CD138 Positive Selection Kit (100-0748) |
STEMCELL Technologies Canada Inc. |
Jason Peng |
| K222818 |
01/24/2023 |
Xpedition Ö Powered Stair Chair (625700000000) |
Stryker Medical |
Rachel Stallworth |
| K232262 |
11/30/2023 |
LumenEye« X1 endoscope (LX1-SCP-203); LumenEye« X1 consumables (LX1-CSB-201); LumenEye« X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) |
SurgEase Innovations Limited |
Roger Parker |
| K232684 |
11/29/2023 |
Surgify Halo |
Surgify Medical OY |
Jukka Kreander |
| K232725 |
11/02/2023 |
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor |
Suzhou Endophix Co., Ltd. |
Juan Wu |
| K231554 |
11/14/2023 |
UniPearls« Embolic Microspheres |
Suzhou Haowei Medical Technology Co., Ltd. |
Jinyan Shi |
| K222711 |
01/09/2023 |
HS186B Scooter |
Suzhou Master Machinery Manufacturing Co.,Ltd. |
Siqi Shangguan |
| K230287 |
11/21/2023 |
SaviSafe Safety Device |
Suzhou Savicred Biotechnology Co., Ltd. |
Jiajun Zhu |
| K231559 |
11/17/2023 |
Multi-Unit DAS System |
Talladium Espa±a, SL |
Xavier Soca Filella |
| K232382 |
11/03/2023 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
Christin Dunn |
| K232380 |
11/03/2023 |
t:slim X2 Insulin Pump with Interoperable Technology |
Tandem Diabetes Care, Inc. |
Christin Dunn |
| K222577 |
01/06/2023 |
TECHFIT Diagnostic Models |
TECHFIT Digital Surgery Inc. |
David Garcia-Patino |
| K211163 |
01/09/2023 |
Bone Cement Genta, Bone Cement HV, Bone Cement LV |
Tecres S.p.A. |
Massimo Grazioli |
| K232152 |
11/08/2023 |
NerivioInfinity |
Theranica Bioelectronics ltd |
Alon Ironi |
| K221899 |
01/20/2023 |
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K230311 |
11/24/2023 |
HyperSuture |
Threadstone L.L.C. |
Jeremy Clark |
| K203689 |
01/23/2023 |
Tidepool Loop |
Tidepool Project |
Howard Look |
| K231975 |
11/21/2023 |
PNK Total Knee System |
TJC Life Co., Ltd |
Srinu Krotha |
| K232555 |
11/20/2023 |
Harmony |
Topcon Healthcare Solutions |
Tobias Schwarz |
| K222510 |
01/20/2023 |
Blueprint Mixed Reality system |
Tornier SAS |
Moyees Kamara |
| K221163 |
01/19/2023 |
Tunnel Crossing Catheter |
Tractus Vascular, LLC |
Janet Burpee |
| K231821 |
11/29/2023 |
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E |
Transit Scientific, LLC |
Jennifer Arnold |
| K221181 |
01/05/2023 |
Treace Medical Concepts (TMC) Plating System |
Treace Medical Concepts Inc. |
Melissa Coloroso |
| K230834 |
11/21/2023 |
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H |
Trismed Co., Ltd. |
Sul Ki Lee |
| K232658 |
11/27/2023 |
T-Top 10 & T-Top T-Top 11 |
Tuttnauer U.S.A Co, Ltd |
Jonathan Lane |
| K221149 |
01/05/2023 |
U-Motion II Acetabular System-Extension line |
United Orthopedic Corporation |
Lois Ho |
| K222531 |
01/22/2023 |
Synthetic Polymer Glove - Polyethylene (Black) |
UR Industry SDN BHD |
Chua Song Han |
| K230646 |
11/29/2023 |
SUREcore Prime Biopsy Instrument |
Uro-1 Medical, Inc. |
Thomas Lawson, PhD |
| K223748 |
01/13/2023 |
Nitrile Exam Gloves (Chemotherapy Drug Tested) |
US Medical Glove Company LLC |
Jorge A. Alcazar |
| K232113 |
11/03/2023 |
Halcyon, Ethos Radiotherapy System |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K222941 |
01/17/2023 |
Halcyon, Ethos Radiotherapy System |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K220114 |
01/25/2023 |
PowerPAK Syringe |
Vault Paragon Group, Inc. |
Sari Luciano |
| K232092 |
11/14/2023 |
Great Basin Toxigenic C. difficile Direct Test (CDF2) |
Vela Operations USA |
Larry Rea |
| K230326 |
11/02/2023 |
ENFit to ENFit Extension Sets |
Vesco Medical |
Chris O'Keefe |
| K223031 |
01/13/2023 |
Vibrant System |
Vibrant Ltd. |
Martha Bezalel |
| K223117 |
01/31/2023 |
V-SPERM WASH |
Vitromed GmbH |
Greg Holland |
| K233062 |
11/02/2023 |
BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx |
VivaChek Biotech (Hangzhou) Co., Ltd |
Jessica Chen |
| K230947 |
11/28/2023 |
C.A.R.E. Appliance (DNA, mRNA, mmRNA) |
Vivos Therapeutics, Inc |
Kimberly Griffith |
| K223516 |
01/21/2023 |
VX1+ |
Volta Medical |
Paola Milpied |
| K223412 |
01/06/2023 |
LumiVyÖ Lumbar IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K231445 |
11/16/2023 |
LINK Embrace Shoulder System - Reverse Configuration |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K221754 |
01/17/2023 |
Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) |
Winner Medical Co., Ltd. |
Zhiqin Liang |
| K221755 |
01/13/2023 |
Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing |
Winner Medical Co., Ltd. |
Zhiqin Liang |
| K221532 |
01/30/2023 |
PHMB Wound Dressing |
Winner Medical Co., Ltd. |
Yi Fu |
| K231564 |
11/10/2023 |
Skin and Wound Cleanser |
Winner Medical Co., Ltd. |
Mingni Liu |
| K221379 |
01/04/2023 |
Steriking LT-Blueline Pouches with Tyvek |
Wipak OY |
Hanna Marttila |
| K222835 |
01/27/2023 |
Prophecy Preoperative Navigation Alignment System |
Wright Medical Technology, Inc. |
Paxia Her |
| K232538 |
11/17/2023 |
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL |
WRP Asia Pacific Sdn. Bhd. |
Muhammad Ameer Arief Mohd Mujab |
| K232117 |
11/28/2023 |
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) |
Wuhan Lotuxs Technology Co., Ltd. |
Na Wu |
| K222879 |
01/24/2023 |
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) |
Wuxi Jiajian Medical Instrument Co., Ltd |
Wu Zhifang |
| K221200 |
01/31/2023 |
XBody Go USA, XBody Pro USA |
XBody Hungary Kft. |
Orsolya Balog |
| K223411 |
01/04/2023 |
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) |
Xiamen Probtain Medical Techology Co., Ltd |
Jianli Kang |
| K223250 |
01/19/2023 |
Disposable Nitrile Examination Glove |
Yangzhou Saraguard Medical Supplies Co.,Ltd. |
Guo Hua |
| K221627 |
01/19/2023 |
PerfusionGo Plus |
Yukun (Beijing) Technology Co., Ltd. |
Qi Wang |
| K221726 |
01/18/2023 |
Uni-FuZe-C Bone Strip |
Zavation Medical Products, LLC |
Elke Carter |
| K222782 |
01/13/2023 |
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) |
Zhejiang Carebao Co., Ltd. |
Xie Yan |
| K230773 |
11/21/2023 |
Endoscopy Irrigation Tubing |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K231508 |
11/09/2023 |
Power Wheelchair, W5521 |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
Grace Li |
| K232442 |
11/09/2023 |
Disposable Endoscope Injection Needles |
Zhejiang Soudon Medical Technology Co.,Ltd |
Junshi Wang |
| K232476 |
11/07/2023 |
Disposable Sphincterotome |
Zhejiang Soudon Medical Technology Co.,Ltd |
Wang Junshi |
| K231692 |
11/20/2023 |
Ziehm Vision RFD |
Ziehm Imaging GmbH |
Stefan Fiedler |
| K230627 |
11/20/2023 |
Zilia Ocular FC (ZIL-10002) |
Zilia Inc. |
Sauvageau Patrick |
| K211047 |
01/10/2023 |
CoCr Head |
Zimmer GmbH |
Roberto Tommasini |
| K233443 |
11/16/2023 |
VitalÖ Navigation System |
ZimVie Spine (Zimmer Biomet Spine, Inc.) |
Anjanet Mort |
| K231182 |
11/03/2023 |
Thermogard HQÖ Temperature Management System, Thermogard XP« Temperature Management System |
ZOLL Circulation, Inc |
Sean Manning |
| K223746 |
01/13/2023 |
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console |
Zoll Circulation, Inc. |
Brian Robey |
