| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K222578 |
05/18/2023 |
3MÖ IobanÖ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) |
3M Company |
Hilary Hovde |
| K231464 |
05/22/2023 |
3MÖ ClarityÖ Aligners (3MÖ ClarityÖ Aligners-Force, 3MÖ ClarityÖ Aligners-Flex) |
3M Company, Unitek Orthodontic Products |
Brittany Randolph |
| K231338 |
05/10/2023 |
3MÖ ClinproÖ Clear 2.1% Sodium Fluoride Treatment |
3M ESPE Dental Products |
Chandrapaul Parsram |
| K230790 |
05/19/2023 |
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series |
Abbott Laboratories |
Melissa Vaughan |
| K230994 |
05/04/2023 |
Alinity i STAT High Sensitivity Troponin-I |
Abbott Laboratories Diagnostics Division |
Judi Wallach |
| K230286 |
05/17/2023 |
Assert-IQÖ Insertable Cardiac Monitor |
Abbott Medical |
Laura Sparks |
| K230934 |
05/03/2023 |
ViewFlexÖ Eco Reprocessed ICE Catheter |
Abbott Medical |
Quynh Phuong Le |
| K223725 |
05/18/2023 |
Restrata« MiniMatrix |
Acera Surgical, Inc. |
Tamas Kovacs |
| K230606 |
05/02/2023 |
AcQMap« High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Subhadra Elango |
| K223276 |
05/18/2023 |
Anchor Bolts as Accessories to Depth Electrodes |
Ad-Tech Medical Instrument Corporation |
Brendan McCrea |
| K223269 |
05/18/2023 |
Spencer Probe Depth Electrodes |
Ad-Tech Medical Instrument Corporation |
Brendan McCrea |
| K230803 |
05/23/2023 |
ADAS 3D |
Adas3D Medical S.L |
Antoni Riu |
| K223805 |
05/04/2023 |
Agnes |
Agnes Medical Co., Ltd |
Jiwon Kim |
| K222987 |
05/10/2023 |
Akunah REFLECT |
Akunah PTY LTD |
Shanthan Pather |
| K220781 |
05/05/2023 |
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter |
Allwin Medical Devices, Inc |
Digish Mehta |
| K230721 |
05/09/2023 |
ATEC Lateral Plate System |
Alphatec Spine, Inc. |
Aditya Aiyer |
| K230340 |
05/04/2023 |
Lucas Plus |
AMT Engineering Co., Ltd |
SeoungSoo Choi |
| K223860 |
05/22/2023 |
IntegrityÖ Bone Staple Fixation System |
Anika Therapeutics Inc. |
Shajunath Nirupama |
| K222487 |
05/08/2023 |
Anika Tissue Tack Fixation System |
Anika Therapeutics, Inc. |
Shajunath Nirupama |
| K213289 |
05/26/2023 |
Gammex« PI Plus Glove-in-GloveÖ System Tested For Use with Chemotherapy Drugs |
Ansell Healthcare Products, LLC |
Tammy McGriff |
| K230631 |
05/22/2023 |
KodiakÖ Dual Port Coaxial Introducer Kit |
Argon Medical Devices |
Pratusha Kudumula |
| K220759 |
05/25/2023 |
Armis VeriCyn Wound Wash |
Armis Biopharma, Inc. |
Angela Mallery |
| K231113 |
05/18/2023 |
Arthrex FiberTak Suture Anchor |
Arthrex Inc. |
Kristi Frisch |
| K222097 |
05/04/2023 |
OLYMPIC Deformity Band System |
Astura Medical |
Parker Kelch |
| K223335 |
05/09/2023 |
SIRION Lateral Lumbar Interbody System |
Astura Medical |
Parker Kelch |
| K222035 |
05/24/2023 |
Avatar Medical Software V1 |
Avatar Medical |
Elodie Brient-Litzler |
| K230571 |
05/30/2023 |
RFP-100A Connector Cable (Single Use) |
Baylis Medical Technologies Inc. |
Gallone Stephanie |
| K213280 |
05/04/2023 |
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App |
BD Kiestra B.V. |
Karin Brands |
| K223846 |
05/19/2023 |
iLet« ACE Pump |
Beta Bionics, Inc |
Vikram Verma |
| K220916 |
05/19/2023 |
iLet« Dosing Decision Software |
Beta Bionics, Inc. |
Vikram Verma |
| K221897 |
05/30/2023 |
Hydrozid Precise |
BIBAWO Medical A/S |
Sandra Larsen |
| K223907 |
05/02/2023 |
NuEra Tight RF Model APMD145.M70-US |
BIOS s.r.l. |
Martina De Iturbe |
| K230375 |
05/19/2023 |
BIOMONITOR IV |
BIOTRONIK, Inc. |
Jon Brumbaugh |
| K231176 |
05/25/2023 |
Stingray LP Catheter |
Boston Scientific |
Gabrielle Reynolds |
| K230453 |
05/18/2023 |
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter |
Boston Scientific Corporation |
Cassie Clark |
| K223645 |
05/18/2023 |
I.V. Administration Set, I.V. Extension Set |
BQ PLUS Medical Co., Ltd |
Jin Zhang |
| DEN220027 |
05/18/2023 |
B╖R╖A╖H╖M╖S sFlt-1/ PlGF KRYPTOR Test System |
BRAHMS GmbH, Part of Thermo Fisher Scientific |
Anja Jagalla |
| K231052 |
05/11/2023 |
ExacTrac Dynamic 1.1.2 |
Brainlab AG |
Sadwini Suresh |
| K222556 |
05/31/2023 |
BTL-785X |
BTL Industries Inc. |
David Chmel |
| K222484 |
05/09/2023 |
Retitrack |
C. Light Technologies, Inc. |
Christy K Sheehy-Bensinger |
| K222854 |
05/12/2023 |
iTFlow |
Cardio Flow Design Inc. |
Teruyasu Nishino |
| K220526 |
05/15/2023 |
HD+12, HD+15 |
Cardioline S.P.A |
Antonella Bornacin |
| K223101 |
05/12/2023 |
BD Secondary Infusion Set |
CareFusion |
Paulina Davis |
| K230121 |
05/15/2023 |
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) |
Careglove Global SDN. BHD. |
Lim Kwee Shyan |
| K231140 |
05/19/2023 |
aprevo« transforaminal lumbar interbody fusion device |
Carlsmed, Inc. |
Karen Liu |
| K223655 |
05/09/2023 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K230674 |
05/08/2023 |
JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 |
CC Wellness LLC |
Marlent Perez |
| K212758 |
05/19/2023 |
Autoplaque |
Cedars-Sinai Medical Center: AIM |
Damini Dey |
| K230564 |
05/23/2023 |
Green Non Sterile Powder Free Nitrile Examination Gloves |
Central Medicare Sdn Bhd |
Ang Shiao Ping |
| K223504 |
05/23/2023 |
Ceribell Status Epilepticus Monitor |
Ceribell, Inc. |
Raymond Woo |
| K222229 |
05/25/2023 |
Advanced LumFix Spinal Fixation System |
CG Bio Co., Ltd. |
Iris Kim |
| K222311 |
05/25/2023 |
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System |
CIRCA Scientific, Inc. |
Fred Piazza |
| K231178 |
05/23/2023 |
ACTERAÖ hip system |
Conformis Inc |
Mary Kruitwagen |
| K231233 |
05/26/2023 |
IdentityÖ ImprintÖ CR KRS and IdentityÖ ImprintÖ PS KRS |
Conformis, Inc. |
Nivedita Namjoshi |
| K230030 |
05/30/2023 |
Excipio SV Aspiration Catheter and Tubing |
Contego Medical, Inc. |
James Clossic |
| K222254 |
05/16/2023 |
Gunther Tulip Vena Cava Filter Retrieval Set |
Cook Incorporated |
Daniel Corbin |
| K230909 |
05/30/2023 |
EchoTip« AcuCoreÖ Ultrasound Biopsy Needle (ECHO-BX-3-22) |
Cook Ireland Ltd. |
Laura O'Reilly |
| K230880 |
05/02/2023 |
CoreLink Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K231143 |
05/19/2023 |
GI Genius System 100 and GI Genius System 200 |
Cosmo Artificial Intelligence - AI Ltd |
Nhan Ngo Dinh |
| K223809 |
05/30/2023 |
PrecisionTAVI (v1.1) |
DASI Simulations |
Ana Minyayev |
| K230448 |
05/17/2023 |
DeepX DermoSight Dermatoscope |
DeepX Health LLC |
Laurens Kraal |
| K230203 |
05/03/2023 |
Dentis I-FIX Abutment |
Dentis Co., Ltd. |
EunJin Shin |
| K230246 |
05/25/2023 |
Dentis s-Clean SQ-SL Narrow Implant System |
Dentis Co., Ltd. |
EunJin Shin |
| K230523 |
05/24/2023 |
s-Clean Link Abutment Narrow |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K223756 |
05/04/2023 |
SimProÖ Now, GentleCathÖ Hydrophilic |
Dentsply Sirona |
Laura Sobrin |
| K231081 |
05/15/2023 |
Dexcom G7 Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Bob Shen |
| K222356 |
05/18/2023 |
Claritag Advanced |
DGI Technologies |
Jeremy Josephson |
| K230278 |
05/30/2023 |
Babyroo TN300 |
Draeger Medical Systems, Inc. |
Karl Nittinger |
| K222207 |
05/16/2023 |
Babylog VN800, Babylog VN600 |
Draegerwerk AG & CO KGaA |
Nataliia Semenova |
| K222024 |
05/16/2023 |
Evita V800, Evita V600 |
Draegerwerk AG & Co. KGaA |
Holger Nadler |
| K223651 |
05/26/2023 |
Cerebral Adaptive Index (CAI) Algorithm |
Edwards Lifesciences, LLC |
Sara Pesian |
| K230684 |
05/12/2023 |
RadiForce MX217 |
EIZO Corporation |
Hiroaki Hashimoto |
| K230111 |
05/26/2023 |
CORE 500 Digital Stethoscope |
Eko Devices, Inc. |
Sam Huang, Ph.D. |
| K230460 |
05/22/2023 |
Laser Thermal Therapy Kit |
Elesta SPA |
Fabio Andreola |
| K222388 |
05/04/2023 |
swiftPro System |
Emblation Ltd. |
Mairi MacFayden |
| K230219 |
05/16/2023 |
Eminent Spine 3D Lumbar Interbody Fusion Systems |
Eminent Spine, LLC |
Stephen Courtney |
| K230358 |
05/16/2023 |
SAVI Dual (TM) Migraine Therapy |
eNeura, Inc. |
David Rosen |
| K230769 |
05/19/2023 |
PrevisEA Device |
Entac Medical Inc. |
Buddy Lyons |
| K222460 |
05/12/2023 |
Intraoperative Ultrasound Probe Cover |
Exact Medical Manufacturing |
Ryan Power |
| K221323 |
05/19/2023 |
Exactech« Alteon« Short Tapered Wedge |
Exactech, Inc |
Valdimir Talley |
| K230258 |
05/25/2023 |
BB 8 Sinus Dilation Kit |
Excelent Inc. |
Kashif Mazhar |
| K213010 |
05/31/2023 |
FEELject LDV (Low dead volume) syringe |
Feeltech Co., Ltd. |
Kim Geun Sik |
| K230065 |
05/26/2023 |
VenSureÖ Balloon Dilation System, VenSureÖ Light Balloon Dilation System, VenSureÖ Nav Balloon Dilation System, VenSureÖ ET Balloon Dilation System |
Fiagon GmbH |
Dirk Mucha |
| K230958 |
05/30/2023 |
First Glove Blue Nitrile Examination Gloves Powder Free |
First Glove Sdn. Bhd. |
Dean Segal |
| K223696 |
05/17/2023 |
F&P Solo Mask Range |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K223843 |
05/03/2023 |
FloPatch FP120 |
Flosonics Medical |
Caleb Chin |
| K220829 |
05/18/2023 |
Endo Motor |
Foshan COXO Medical Instrument Co., Ltd. |
Yongjian Zheng |
| K213992 |
05/31/2023 |
CombiSet Hemodialysis Blood Tubing Set |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K220721 |
05/11/2023 |
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K230280 |
05/11/2023 |
ANDORATE« Suction Valve and ANDORATE« Biopsy Valve |
GA Health Company Limited |
Cindy Ye |
| K230708 |
05/22/2023 |
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 |
| K230082 |
05/04/2023 |
Auto Segmentation |
GE Medical Systems, LLC |
Niki Mavrodieva |
| K223491 |
05/25/2023 |
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite |
GE Medical Systems, LLC |
Chris Paulik |
| K223523 |
05/30/2023 |
Sonic DL |
GE Medical Systems,LLC (GE Healthcare) |
Glen Sabin |
| K230679 |
05/26/2023 |
WellsForm Tricuspid Annuloplasty Band (WF) |
Genesee Biomedical Inc |
Woodrow Mathison |
| K230217 |
05/13/2023 |
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs |
Grand Work Plastic Products Co., Ltd |
Wu Yuli |
| K230615 |
05/05/2023 |
Electric Scooter (Model: S3312) |
Guangdong Prestige Technology Co., Ltd. |
Zhang Zhao |
| K222891 |
05/25/2023 |
Dental Desensitizer |
Guangzhou Beogene Biotech Co., Ltd |
Duan Qiangqiang |
| K222545 |
05/19/2023 |
Disposable Medical Mask |
Guangzhou Fuzelong Hygiene Material Co., Ltd |
Haiyan Zeng |
| K223329 |
05/26/2023 |
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) |
Guangzhou Yongyi Industrial Co., Ltd. |
Wei Hu |
| K222421 |
05/03/2023 |
Sphincterotome |
Hangzhou AGS MedTech Co., Ltd. |
Jiayuan Zhang |
| K223495 |
05/02/2023 |
Zeolite Hemostatic Cotton |
Hangzhou Zeo-Innov Life Technology Co., Ltd |
Zhao Lijuan |
| K223437 |
05/17/2023 |
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) |
Hartalega NGC SDN. BHD. |
Kuan Mun Leong |
| K222489 |
05/12/2023 |
Harvest Printable Resin |
Harvest Dental Products, LLC |
Colleen Boswell |
| K230432 |
05/18/2023 |
Single Use Bipolar Forceps |
HG Innovations Ltd |
Dr.M Umran Rafiq |
| K223308 |
05/13/2023 |
HEATING TENS/EMS, FT-810R |
Hivox Biotek Inc. |
Shaun Hsu |
| K223280 |
05/08/2023 |
Disposible Nitrile Gloves |
HOLIK ASIA GROUP CO., LTD |
Monica Zhou |
| K230096 |
05/23/2023 |
Genius AI Detection 2.0 with CC-MLO Correlation |
Hologic, Inc. |
Deborah Thomas |
| K231017 |
05/05/2023 |
Panther Fusion AdV/hMPV/RV Assay |
Hologic, Inc. |
Jon Kukowski |
| K222736 |
05/16/2023 |
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay |
Hologic, Inc. |
Vlada Rudenko |
| K230134 |
05/23/2023 |
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 |
Hubei YJT Technology Co.,Ltd |
Hua Xinag |
| K230619 |
05/04/2023 |
Hubly Electric Drill (H100) |
Hubly Inc. |
Casey Grage |
| K230542 |
05/31/2023 |
Disposable Nitrile Gloves (ABC-DG01) |
Huizhou Anboson Technology Co., Ltd. |
Xuanli Weng |
| K223706 |
05/12/2023 |
PMMA BLOCK |
Huliang(shanghai) Bio-Tech Co., Ltd. |
Quansheng Wang |
| K230491 |
05/10/2023 |
HandXÖ Monopolar Scissors |
Human Xtensions Ltd. |
Hani Rauch |
| K230200 |
05/18/2023 |
Single-Use Flexible Ureteroscope |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K223836 |
05/15/2023 |
Vathin« Video Bronchoscope System |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K203599 |
05/26/2023 |
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System |
Immuno Concepts N.A., Ltd. |
Eric S. Hoy |
| K230530 |
05/04/2023 |
SOZO Pro |
ImpediMed Limited |
Dennis Schlaht |
| K230531 |
05/04/2023 |
SOZO Pro |
ImpediMed Limited |
Dennis Schlaht |
| K231168 |
05/22/2023 |
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support |
Imperative Care Inc. |
Shivani Patel |
| K230912 |
05/02/2023 |
Artix BG |
Inari Medical |
Ellen Nguyen |
| K222560 |
05/16/2023 |
BlueCheckÖ Caries Detection & Monitoring |
Incisive Technologies Pty Ltd |
Kerry A Hegarty |
| K223511 |
05/02/2023 |
Excella Navigation Instruments |
Innovasis, Inc. |
Michael Thomas |
| K231259 |
05/31/2023 |
iRoot SP Plus |
Innovative BioCeramix, Inc. |
Quanzu Yang |
| K222836 |
05/15/2023 |
Straumann« Variobase« Abutments and Straumann« n!ce« Zirconia discs |
Institut Straumann AG |
Dr. Renate Reiss |
| K230316 |
05/26/2023 |
FlexBand; FlexPatch; FlexBand Plus |
International Life Sciences |
Tiffini Wittwer |
| K231224 |
05/12/2023 |
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) |
Intuitive Surgical, Inc. |
Michael Prutton |
| K223624 |
05/10/2023 |
Emerald Herbst |
Island Dental Lab, Inc dba Emerald Dental |
Israel Wettenstein |
| K230938 |
05/03/2023 |
ARIX Humerus System |
Jeil Medical Corporation |
Bora Kim |
| K230593 |
05/30/2023 |
Victan |
Jiangsu Haize Medical Scientific Development Co., Ltd. |
Vincy Gao |
| K212857 |
05/09/2023 |
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use |
Jiangsu Zhiyu Medical Instrument Co, Ltd. |
Lianhua Cao |
| K230443 |
05/22/2023 |
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) |
Jiangxi Royall Smart Technology Co., Ltd. |
Shunzhou Yang |
| K223259 |
05/24/2023 |
coactiv+Ö Antimicrobial Wound Gel |
Kane Biotech, Inc. |
Lori Christofalos |
| K223814 |
05/25/2023 |
Genesis ACTIVE Implant System |
Keystone Dental Inc. |
Nancy DeAngelo |
| K222624 |
05/25/2023 |
KLS Martin LINOS Wrist System |
KLS-Martin L.P. |
Melissa Bachorski |
| K230373 |
05/22/2023 |
HELIOS 785 Pico |
Laseroptek Co., Ltd. |
Hong Chu |
| K230601 |
05/28/2023 |
Blue Nitrile Examination Gloves Powder Free |
Latrile Gloves Private Limited |
M Ragu |
| K230044 |
05/26/2023 |
Pre-Sure |
Lazarus 3D |
Smriti Zaneveld |
| K223430 |
05/04/2023 |
ProLift Micro Expandable Spacer System |
Life Spine, Inc. |
Angela Batker |
| K223893 |
05/16/2023 |
Infrared Heat (Model: E0221) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K230266 |
05/04/2023 |
Orchid Safety Release Valve |
Linear Health Sciences, LLC |
Daniel Clark |
| K223486 |
05/19/2023 |
SafeBreak« Vascular |
Lineus Medical |
Vance Clement |
| K230479 |
05/18/2023 |
ComASP Cefiderocol 0.008-128 |
Liofilchem s.r.l. |
Fabio Brocco |
| K221634 |
05/24/2023 |
Oxymag - Transport and Emergency Ventilator |
Magnamed Tecnologia Medica S/A |
Toru Kinjo |
| K230123 |
05/03/2023 |
Apollo Knotless Suture Anchor |
Maruho Medical |
Yannick Spenninck |
| K231391 |
05/15/2023 |
Combi Touch |
Mectron S.p.A. |
Edoardo Tronchet |
| K220706 |
05/30/2023 |
MyPAO Guides |
Medacta International S.A. |
Stefano Baj |
| K221870 |
05/01/2023 |
CarnaLife Holo |
MedApp S.A. |
Andrzej Skalski |
| K230465 |
05/22/2023 |
Hi-Bond Universal |
Mediclus Co., LTD. |
Hyeon-A Jo |
| K212743 |
05/03/2023 |
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System |
MedSchenker, Inc. |
Joseph Kim |
| K231184 |
05/26/2023 |
CD HorizonÖ Spinal System |
Medtronic Sofamor Danek, USA Inc. |
Justin OÆConnor |
| K230960 |
05/04/2023 |
DLPÖ Silicone Coronary Artery Ostial Cannulae |
Medtronic, Inc. |
Stephen Beier |
| K222436 |
05/09/2023 |
LatitudÖ Hip Replacement System |
Meril Healthcare Pvt. Ltd. |
Yamini Patel |
| K230851 |
05/26/2023 |
Kodiak Lumbar Spacer System |
Met One Technologies, LLC |
Adrian Carbonell |
| K231032 |
05/10/2023 |
AMP by Method Mobility, AMP Plus (or +) by Method Mobility |
Method Mobility |
Paul Dickie |
| K202963 |
05/05/2023 |
ELEC Master, ELEC Master Dual |
Mgnewton Ltd. |
Byoung-Wook Ahn |
| K222979 |
05/19/2023 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W |
Microlife Intellectual Property GmbH |
Ariel Wang |
| K202993 |
05/15/2023 |
Buzzy« (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool« (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) |
MMJ Labs, LLC |
Amy Baxter |
| K222703 |
05/19/2023 |
ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX) |
Moving Life Ltd |
Igor Naroditsky |
| K223147 |
05/14/2023 |
myLEDmask |
myBlend |
ClΘdia Hettinger |
| K230106 |
05/24/2023 |
General Cutting Straight |
Nakanishi Inc. |
Masaaki Kikuchi |
| K230723 |
05/18/2023 |
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
Donny Lee |
| K230643 |
05/01/2023 |
CP620G LCD monitor, CP620 LCD monitor |
Nanjing Jusha Display Technology Co., Ltd |
Donny Lee |
| K220437 |
05/10/2023 |
Neurophet AQUA |
NEUROPHET, Inc. |
Boreum Yoo |
| K230975 |
05/12/2023 |
Ahmed« Glaucoma Valve Model FP7 |
New World Medical, Inc. |
Victor Arellano |
| K231051 |
05/12/2023 |
Ahmed« Glaucoma Valve Model FP8 |
New World Medical, Inc. |
Victor Arellano |
| K223529 |
05/02/2023 |
PressON Spinal Fixation System |
Nexus Spine, LLC |
Jared Crocker |
| K222644 |
05/31/2023 |
Nihon Kohden NKV-440 Ventilator System |
Nihon Kohden OrangeMed, Inc. |
Sheryl Higgins |
| K222852 |
05/25/2023 |
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle |
Nipro Medical Corporation |
Jessica Oswald-McLeod |
| K203245 |
05/04/2023 |
Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C |
Nucleix Ltd. |
Shmulik Adler |
| K230989 |
05/05/2023 |
Rod Registration Frame |
NuVasive, Incorporated |
Leah Andre |
| K220402 |
05/19/2023 |
VirtuOst |
O.N. Diagnostics |
David Kopperdahl |
| K222359 |
05/30/2023 |
Quicktome Software Suite |
Omniscient Neurotechnology Pty Ltd (O8t) |
Jennifer Dixon |
| K212579 |
05/02/2023 |
FortiShield (Biosynthetic Wound Matrix) |
Organogenesis Inc. |
Christina Nichols |
| DEN210038 |
05/05/2023 |
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator |
Ortho-Clinical Diagnostics, Inc. |
Marlene Hanna |
| DEN210040 |
05/05/2023 |
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators |
Ortho-Clinical Diagnostics, Inc. |
Marlene Hanna |
| K222847 |
05/04/2023 |
Ceramic Brackets Orthometric |
Orthometric - Industria e Comercio de Produtos Medicos |
Silvio Zilio |
| K231162 |
05/23/2023 |
ROSA Hip System |
Orthosoft, Inc (d/b/a Zimmer CAS) |
Victorien Thiaux |
| K231326 |
05/31/2023 |
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) |
Osteonic Co., Ltd. |
Da Kyung Ham |
| K211056 |
05/31/2023 |
Oxus Sieve Beds |
Oxus, Inc. |
Ryan Lenarcic |
| K230550 |
05/11/2023 |
JAWS Nitinol Staple System |
Paragon 28 Inc |
Haylie Hertz |
| K221768 |
05/05/2023 |
Oxfore«100 (hexafocon A) Rigid Gas Permeable Contact Lenses |
Paragon Vision Sciences, Inc. |
Vimala Punsammy |
| K222885 |
05/31/2023 |
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) |
Pegavision Corporation |
Estela Lin |
| K221779 |
05/02/2023 |
ASEPT Peritoneal Drainage System |
PFM Medical, Inc. |
Jessica Jho |
| K223771 |
05/04/2023 |
Lumify Diagnostic Ultrasound System |
Philips Ultrasound |
Sudipta Chakrabarti |
| K231190 |
05/12/2023 |
EPIQ Series Diagnostic Ultrasound System |
Philips Ultrasound LLC |
Courtney Nix |
| K223023 |
05/09/2023 |
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
Plasmapp Co,.Ltd. |
Byeong Geon Song |
| K231169 |
05/25/2023 |
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
Plasmapp Co., Ltd. |
Seung Hun Lee |
| K223015 |
05/09/2023 |
STERLINKÖ FPS-15s Plus sterilizer with STERPACKÖ plus cassette |
Plasmapp Co., Ltd. |
Byeong Geon Song |
| K223025 |
05/09/2023 |
Tyvek Roll with CI for STERLINK Sterilizer |
Plasmapp Co., Ltd. |
Byeong Geon Song |
| K220322 |
05/04/2023 |
Pollogen STOP U Model UXV Device |
Pollogen Ltd. |
Elissa Burg |
| K230616 |
05/05/2023 |
Polyguard and Polyshield Safety IV Catheters |
Poly Medicure Limited |
Ramdas Sharma |
| K231229 |
05/25/2023 |
S-COMP Reform« POCT Navigation Instruments |
Precision Spine, Inc. |
Michael Dawson |
| K230262 |
05/16/2023 |
BruxZirÖ Incisal Coloring Liquid |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
| K222549 |
05/11/2023 |
OpenTex |
Purgo Biologics Inc. |
Byungsun Kim |
| K223758 |
05/03/2023 |
Epione |
Quantum Surgical SAS |
Elise Lagacherie |
| K220842 |
05/19/2023 |
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors |
Qura S.r.l. |
Raffaella Tommasini |
| K223620 |
05/24/2023 |
Reprieve by RegenesisTM |
Regenesis Biomedical Inc. |
Randy Chavez |
| K223096 |
05/26/2023 |
Dark Star Deformity Pedicle Screw System |
Republic Spine, LLC |
James Doulgeris |
| K222416 |
05/01/2023 |
RIA Safeguard |
RIA Tech Co., Ltd. |
David Chao |
| K230119 |
05/02/2023 |
3D Anatomic Model |
Ricoh USA, Inc. |
Gary Turner |
| K231128 |
05/17/2023 |
JuggerKnot Soft Anchor |
Riverpoint Medical LLC |
Rebecca DeFrancia |
| K223841 |
05/30/2023 |
KBA3D |
S.M.A.I.O. |
Jean-Charles Roussouly |
| K230292 |
05/02/2023 |
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification |
Samsung Electronics Co., Ltd |
Hon Pak |
| K230273 |
05/25/2023 |
Saranas Early Bird Bleed Monitoring System |
Saranas Inc. |
Odell Roberts |
| K222812 |
05/16/2023 |
Insufflator |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K230152 |
05/23/2023 |
uMR Omega |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K230758 |
05/18/2023 |
uMR 570 |
Shanghai United Imaging Healthcare Co.,Ltd. |
Xin Gao |
| K223044 |
05/10/2023 |
Digital Thermometer (Model QT001) |
Shen Zhen Rong Feng Technology Co., Ltd |
Hong Xiao Lan |
| K221798 |
05/04/2023 |
Finger Pulse Oximeter, Model: X1906P |
Shenzhen Changkun Technology Co., Ltd. |
Wang Qingpeng |
| K230739 |
05/26/2023 |
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 |
Shenzhen IONKA Medical Technology Co., Ltd. |
Chen Dongfa |
| K223825 |
05/09/2023 |
Tens & Ems Device |
Shenzhen Jian Feng Electronic Technology Co., Ltd |
Feng Wen |
| K222870 |
05/10/2023 |
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 |
Shenzhen Kentro Medical Electronics Co., Ltd |
Zewu Zhang |
| K223428 |
05/08/2023 |
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) |
Shenzhen Leqing Medical Instrument Co., Ltd |
Shaodong Wang |
| K230351 |
05/05/2023 |
LED Facial Mask |
Shenzhen SUNGPO HI-TECH Electronic Co., Ltd |
Ava Hu |
| K230259 |
05/25/2023 |
Soreal Press, Soreal CAD |
Shenzhen UP3d Technology Co., Ltd. |
Judy Zhang |
| K222926 |
05/05/2023 |
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 |
Shenzhen Yuezhongxing Technology Co., Ltd. |
Yuchao Chen |
| K231102 |
05/17/2023 |
Symbia Pro.specta VA20A Family |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K221127 |
05/10/2023 |
Sientra, inc. Portfinder |
Sientra, Inc. |
Denise Dajles |
| K230655 |
05/03/2023 |
PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw |
Signature Orthopaedics Pty Ltd |
Declan Brazil |
| K223663 |
05/24/2023 |
SIMDA Abutment |
SIMDA Co., Ltd. |
Young Woo Cha |
| K223318 |
05/10/2023 |
Internal Joint Stabilizer - Elbow |
Skeletal Dynamics, Inc. |
Alexandra Rodriguez Rojas |
| K230580 |
05/26/2023 |
Diode Laser System |
Smedtrum Medical Technology Co., Ltd. |
Crimson Wu |
| K223762 |
05/30/2023 |
Smith & Nephew ACCORDÖ Cable System |
Smith & Nephew |
Allison Francis |
| K220964 |
05/16/2023 |
VERSAJET Hydrosurgery System (III) |
Smith & Nephew Medical Limited |
Zoe Smith |
| K230653 |
05/04/2023 |
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, |
Smith & Nephew, Inc. |
Tyler Kulcsar |
| K222501 |
05/11/2023 |
Regeneten Bioinductive Implant |
Smith and Nephew Inc |
Jenna Horsley |
| K220713 |
05/04/2023 |
Sol-Guard Auto-disable Syringe |
Sol-Millennium Medical Inc. |
Ying Zhao |
| K231063 |
05/12/2023 |
SOMAVAC« 100 Sustained Vacuum System |
SOMAVAC Medical Solutions, Inc. |
Phil Ryan |
| K222833 |
05/19/2023 |
VentanaÖ C Spinal System |
Spinal Elements, Inc. |
Julie Lamothe |
| K230416 |
05/19/2023 |
Triathlon« Hinge Knee System; Triathlon« Revision Insert X3« |
Stryker |
Allison Byrne |
| K223623 |
05/11/2023 |
SubtleMR (2.3.x) |
Subtle Medical Inc. |
Ajit Shankaranarayanan |
| K230263 |
05/26/2023 |
FinesseÖ Injectable PTA Balloon Dilatation Catheter |
Summa Therapeutics, LLC |
Timothy Murphy |
| K230977 |
05/02/2023 |
SIS System |
Surgical Information Sciences, Inc. |
Ann Quinlan-Smith |
| K221067 |
05/31/2023 |
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter |
Surgical Instrument Service and Savings Inc. |
Stephanie Boyle Mays |
| K230874 |
05/23/2023 |
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath |
Suzhou Endophix Co., Ltd. |
Juan Wu |
| K222640 |
05/26/2023 |
Sweden & Martina Surgical Trays |
Sweden & Martina S.p.A. |
Alessia Pezzato |
| DEN220083 |
05/09/2023 |
Stanza |
Swing Therapeutics, Inc. |
Michael Rosenbluth |
| K223626 |
05/26/2023 |
Niti-S Biliary Speed D Stent |
Taewoong Medical Co., Ltd |
Jangsoo Lee |
| K230394 |
05/12/2023 |
EUROSCREW NG; EUROSCREW TCP NG |
Teknimed |
Fabian Marcq |
| K230537 |
05/19/2023 |
Klassic Knee Revision System |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K230957 |
05/02/2023 |
TriSalus TriNav« LV Infusion System |
TriSalus Life Sciences |
Michael Aymami |
| K230614 |
05/02/2023 |
CortiumÖ |
ulrich medical USA |
Hans Stover |
| K222728 |
05/17/2023 |
Radiation Planning Assistant (RPA) |
University of Texas, MD Anderson Cancer Center |
Stella Tsai |
| K220290 |
05/04/2023 |
Revitalair 430+ |
US Hyperbaric Network |
Jorge Millan |
| K230557 |
05/26/2023 |
Eclipse Treatment Planning System (v18.0) |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K223839 |
05/22/2023 |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K230637 |
05/05/2023 |
Wattson temporary pacing guidewire (2250) |
Vascular Solutions LLC |
Vite Beka |
| K230948 |
05/03/2023 |
BFlexÖ 2 Slim 3.8 Single-Use Bronchoscope |
Verathon Medical (Canada) ULC |
Chauneen L Wood |
| K223595 |
05/01/2023 |
vPATCH |
Virility Medical, Ltd. |
Tal Golan |
| K223818 |
05/25/2023 |
Model 9160 VitaloQUB |
Vitalograph Ireland Ltd. |
Tony O'Hanlon |
| K222606 |
05/26/2023 |
V-HYADASE |
VITROMED GmbH |
Greg Holland |
| K230414 |
05/12/2023 |
ClariVyÖ Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K223858 |
05/05/2023 |
Lexa MINI (RIS-303, RIS-305) |
W&H Sterilization S.r.l. |
Paola Zampino |
| K221969 |
05/12/2023 |
IU Implant System Abutment |
Warantec Co., Ltd, |
Younggwang Choi |
| K222106 |
05/12/2023 |
Waypoint GPS |
Waypoint Orthopedics, Inc. |
Tiffini Wittwer |
| K220722 |
05/22/2023 |
PVC Hydrophilic Urethral Catheter |
Well Lead Medical Co., Ltd. |
Jenny Zhu |
| K230464 |
05/22/2023 |
MixJect« Transfer Device |
West Pharma Services IL, Ltd. |
Llanit Goldgraber |
| K222719 |
05/09/2023 |
CX50N |
WIDE Corporation |
YeoJin Yun |
| K222716 |
05/08/2023 |
MX50N |
WIDE Corporation |
YeoJin Yun |
| K223182 |
05/01/2023 |
Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy |
WorldWork S.R.L |
Daniela Baldissera |
| K231137 |
05/19/2023 |
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard |
Xenta Biomedical Science Co., Ltd. |
Huang Ling |
| K230671 |
05/31/2023 |
Pitch PaSoft Tissue Reinforcement Device |
Xiros Ltd |
Steve Curran |
| K222705 |
05/22/2023 |
Introducer Needle |
YouCare Technology Co., Ltd. (Wuhan) |
Bing Hu |
| K223265 |
05/11/2023 |
CryoX Vitrification Freeze Kit / Thaw Kit |
Zhejiang Horizon Medical Technology Co., Ltd |
Wu Tang |
| K222912 |
05/16/2023 |
c1Trac |
Zimmer MedizinSysteme GmbH |
Ute Hauss |
| K213256 |
05/25/2023 |
ThermoTK |
Zimmer MedizinSysteme GmbH |
Ute Hauss |
