| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K222481 |
02/28/2023 |
PuraStat |
3-D Matrix, Inc. |
Lisa Spirio |
| K221943 |
02/01/2023 |
EmbedMed |
3D LifePrints UK Ltd. |
Henry Pinchbeck |
| K223263 |
02/13/2023 |
Prevena Plus 125 Therapy Unit |
3M |
Teri Feeley |
| K230270 |
02/06/2023 |
3MÖ VitCal Liner/Base |
3M ESPE Dental Products |
Chandrapaul Parsram |
| K223362 |
02/02/2023 |
Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device |
4WEB Medical, Inc. |
Lewis Harrison |
| K223537 |
02/21/2023 |
FreeStyle Libre 2 System, FreeStyle Libre 3 System |
Abbott Diabetes Care Inc. |
Simon Yuan |
| K223161 |
02/23/2023 |
OXY-1 System |
Abiomed Inc. |
Ken Ryder |
| K221468 |
02/14/2023 |
CitregenÖ Tendon Interference Screw (TIS), CitrelockÖ Tendon Fixation Device, CitresplineÖ and CitrelockÖ ACL Implants |
Acuitive Technologies, Inc. |
Matthew Poggie |
| K222950 |
02/03/2023 |
AcuPebble OX100 |
Acurable Limited |
Esther Rodriguez-Villegas |
| K222247 |
02/08/2023 |
Hailie Sensor NF0110 |
Adherium (NZ) Ltd |
Tara Creaven-Capasso |
| K223477 |
02/16/2023 |
PMMA Blocks for Dental Use |
Aidite (Qinhuangdao) Technology Co., Ltd. |
Chen Yingying |
| K230020 |
02/01/2023 |
BriefCase |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K223545 |
02/17/2023 |
APRO 70 Catheter and Alembic Aspiration Tubing |
Alembic, LLC |
Lisa Yen |
| K221223 |
02/09/2023 |
extriCARE« 3000 Negative Wound Pressure Therapy System |
Alleva Medical Devices |
Max Choi |
| K230371 |
02/22/2023 |
The Alma Soprano Titanium |
Alma Lasers Inc. |
Jessica Rivera-Montejo |
| K223656 |
02/13/2023 |
AmeriWater MediQA Reverse Osmosis System (MSP3HF) |
AmeriWater, Llc |
Brian Bowman |
| K223338 |
02/09/2023 |
Toothsi, Smilealigners |
AMPA Orthodontics Private Limited |
Manjul Jain |
| K222869 |
02/15/2023 |
Arm Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K221491 |
02/03/2023 |
Anivia SG1000 Pump Console |
APMTD, Inc. |
John Sasso |
| K223262 |
02/23/2023 |
Renuvion« APR Handpiece |
Apyx Medical Corporation |
Mark D. Evans |
| K222341 |
02/13/2023 |
Arrow 0.2 Micron Flat Filter, GVS |
Arrow International, LLC |
Ann Metz |
| K221711 |
02/28/2023 |
AccuICAS |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K223759 |
02/24/2023 |
Arthrex SynergyID Endoscopic Imaging System |
Arthex Inc. |
Troy Brooks |
| K223284 |
02/02/2023 |
SutureLocÖ Implant |
Arthrex Inc. |
Erikka Edwardsen |
| K220715 |
02/10/2023 |
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) |
ARTSMedia Denmark ApS |
Lotte Stroebech |
| K223253 |
02/27/2023 |
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) |
Arumdentistry Co., Ltd. |
Hyang Mi Lee |
| K230012 |
02/02/2023 |
Atomica Planner |
Atomica Technology, Inc. |
Yahia Megahed |
| K213844 |
02/16/2023 |
Surgical Gown |
Bayteks Teknik Tekstil San. ve Tic. A.S. |
Spero Hegbe |
| K210751 |
02/02/2023 |
S.E.A.L. Hemostatic Wound Spray |
BC3 Technologies Inc |
Wayne L. Grube |
| K223679 |
02/03/2023 |
Access AMH |
Beckman Coulter Inc |
Kate Oelberg |
| K223038 |
02/08/2023 |
Access Cortisol |
Beckman Coulter, Inc |
Kuljeet Kaur |
| K222184 |
02/21/2023 |
Introducer Sheath Kits |
Beijing Demax Medical Technology Co., Ltd. |
Anny Zhang |
| K222622 |
02/16/2023 |
Disposable Infusion Bag for Parenteral Nutrition |
Beijing L&Z Medical Technology Development Co., Ltd. |
QiuHong Dong |
| K222579 |
02/23/2023 |
Belun Sleep System BLS-100 |
Belun Technology Company Limited |
Leung Lap Wai Lydia |
| K211181 |
02/27/2023 |
Idylla MSI Test |
Biocartis NV |
Elnaz Jokar |
| K213954 |
02/03/2023 |
BIOFIRE SPOTFIRE Respiratory (R) Panel |
BioFire Diagnostics |
Kevin Bourzac |
| K213863 |
02/23/2023 |
Everion+ System |
Biofourmis Singapore Pte. Ltd |
Milan Shah |
| K214068 |
02/21/2023 |
Quantia IgE |
Biokit, S.A. |
Angels Roma |
| K222073 |
02/09/2023 |
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) |
bioMerieux, Inc |
Kyle J. Olney |
| K223478 |
02/16/2023 |
VITEK« 2 AST-Gram Negative Plazomicin (=0.5 - =16 ╡g/mL); VITEK« 2 AST-GN Plazomicin (=0.5 - =16 ╡g/mL); VITEK« 2 AST-GN Plazomicin |
bioMerieux, Inc |
Cherece L. Jones |
| K223481 |
02/03/2023 |
VITEK« 2 Streptococcus Tetracycline (<=0.25 - >=16 ╡g/mL) |
bioMerieux, Inc |
Jared Bronson |
| K223733 |
02/16/2023 |
CARTO« 3 EP Navigation System with CARTOSOUNDÖ 4D Version 7.4 |
Biosense Webster, Inc. |
Phuong Park |
| K223766 |
02/16/2023 |
NUVISIONÖ NAV Ultrasound Catheter |
Biosense Webster, Inc. |
Sheba Chacko |
| K222695 |
02/17/2023 |
troCarWashÖ System |
Biotex Inc. |
Wade Munsch |
| K222065 |
02/16/2023 |
Passeo-35 Xeo Peripheral Dilatation Catheter |
BioTronik, Inc. |
Jon Brumbaugh |
| K222327 |
02/13/2023 |
Bloomlife MFM-Pro |
Bloom Technologies NV |
Roberto Cunha |
| K221845 |
02/24/2023 |
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G |
Blue Sky Bio, LLC |
Albert Zickmann |
| K230051 |
02/03/2023 |
14F iSLEEVEÖ Introducer Set |
Boston Scientific Corporation |
Kendall Lindenman |
| K221515 |
02/02/2023 |
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring |
Boston Scientific Corporation |
Tanmay Shukla |
| K221564 |
02/23/2023 |
Brainomix 360 e-ASPECTS |
Brainomix Limited |
Gwilym Owen |
| K230175 |
02/15/2023 |
Digital Radiography CXDI-CS01 |
Canon Inc. |
Akira Hirai |
| DEN220063 |
02/24/2023 |
Caption Interpretation Automated Ejection Fraction Software |
Caption Health, Inc |
Tahir Rizvi |
| K223046 |
02/15/2023 |
Xpert« FII & FV |
Cepheid« |
Suzette Chance |
| K222757 |
02/24/2023 |
Clarus Viewer |
Clarus Viewer Corporation |
Steve Thomas |
| K223900 |
02/24/2023 |
babyLance Safety Heelstick (BLM, BLN, BLP) |
Clinical Innovations, LLC |
Alex Garrett |
| K220996 |
02/03/2023 |
Duoblade |
CnC Technologies |
InSang Choi |
| K221874 |
02/15/2023 |
Altis Single Incision Sling System |
Coloplast A/S |
Gayatri Ghadge |
| K230073 |
02/09/2023 |
Okti |
Compumedics Limited |
John Joseph |
| K223897 |
02/17/2023 |
Excipio LV Thrombectomy Device |
Contego Medical Inc. |
Jim Clossick |
| K223648 |
02/03/2023 |
Cook« Spectrum« 2 MRC Central Venous Catheter |
Cook Advanced Technologies |
Matthew Waninger |
| K221592 |
02/24/2023 |
AVIEW Lung Nodule CAD |
Coreline Soft Co.,Ltd. |
Hyeyi Park |
| K223223 |
02/27/2023 |
BENCOX Mirabo Z Cup Cortinium |
Corentec Co., Ltd. |
Songe Kang |
| K230205 |
02/24/2023 |
Veloxion System |
Corinth MedTech, Inc. |
George Hsu |
| K220337 |
02/03/2023 |
GaiaBone Bioabsorbable Bone Graft |
Corliber (Shenzhen) Medical Device Co., Ltd. |
Sun Yang |
| K221629 |
02/22/2023 |
Tri-StapleÖ 2.0 Black Circular Reloads (for use with SigniaÖ Circular Adapters) |
Covidien |
Katherine Y. Choi |
| K211554 |
02/24/2023 |
InnoGenic Non-resorbable Membrane |
Cowellmedi Co., Ltd. |
Minjin Park |
| K221400 |
02/09/2023 |
hygh-tec drainage |
Creative Balloons GmbH |
Claudia Falk |
| K221672 |
02/14/2023 |
Creo Electrosurgical System with NP1 Instrument |
Creo Medical Ltd. |
Tiffany Powell |
| K213030 |
02/13/2023 |
Curiteva Porous PEEK Cervical Interbody Fusion System |
Curiteva, Inc. |
Eric Linder |
| K230227 |
02/23/2023 |
T-Line Hernia Mesh |
Deep Blue Medical Advances, Inc. |
William Perry |
| K222451 |
02/07/2023 |
SAVE GBR |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K222685 |
02/08/2023 |
NIRA Model 2 |
Dermal Photonics Corp |
Felix Feldchtein |
| K222970 |
02/01/2023 |
LVivo IQS |
DiA Imaging Analysis Ltd |
Michal Yaacobi |
| K203211 |
02/09/2023 |
Insulin syringe with integrated needle DL |
DLP Medical Products, Corp. |
Luis Ernesto De La Puente Paniagua |
| K222226 |
02/17/2023 |
EON |
Dominion Aesthetic Technologies, Inc. |
Ahmed Mohammed |
| K221903 |
02/22/2023 |
Delta III Pro |
Dornier MedTech America, Inc |
John Hoffer |
| K230095 |
02/06/2023 |
ScanX Swift 2.0, ScanX Swift View 2.0 |
Durr Dental SE |
Oliver Lange |
| K223249 |
02/10/2023 |
Pro-Tx Endorectal Balloon (PROT-25) |
DxTx Medical, Inc. |
Paul Lawson |
| K223209 |
02/23/2023 |
Elekta Unity |
Elekta Solutions AB |
Melinda Smith |
| K223233 |
02/23/2023 |
Monaco RTP System |
Elekta Solutions AB |
Melinda Smith |
| K223229 |
02/23/2023 |
MOSAIQ« OIS (Oncology Information System) |
Elekta Solutions AB |
Melinda Smith |
| K223884 |
02/24/2023 |
ELITONE Urge Urinary Incontinence Device |
Elidah Inc |
Gloria Kolb |
| K212701 |
02/06/2023 |
Eminent Spine 3D Cervical Interbody Fusion System |
Eminent Spine |
Stephen Courtney |
| K223779 |
02/13/2023 |
EMPOWRÖ blade stem |
Encore Medical LLC |
Trey Thorsen |
| K223891 |
02/15/2023 |
Cobra Catheter System |
Endovascular Engineering |
Debra Cogan |
| DEN220065 |
02/24/2023 |
Pill Sense System |
EnteraSense Ltd. |
David Collins |
| K221513 |
02/17/2023 |
Equashield Closed System Transfer Device |
EQUASHIELD Medical Ltd. |
Michal Levy |
| K221790 |
02/28/2023 |
HARMONIC 700 Shears |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K221980 |
02/06/2023 |
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear |
Ever Global (Vietnam) Enterprise Corporation |
Jerry Lin |
| K223146 |
02/07/2023 |
EVOLUTION SPINE Interbody System |
Evolution Spine |
Todd Wallenstein |
| K223820 |
02/17/2023 |
EzDent-i / E2 / Prora View/ Smart M Viewer |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K223174 |
02/14/2023 |
X-Pac Expandable LLIF Cage System |
Expanding Innovations, Inc. |
Robert Jaramillo |
| K223370 |
02/13/2023 |
NeatNick Heel Safety Lancet |
Facet Technologies LLC |
James Bonds |
| K230118 |
02/16/2023 |
Bony Trauma Extremity System (BTES) Screw Range, NX Nail |
Field Orthopaedics Pty Ltd |
Jillianne McKenzie |
| K223231 |
02/24/2023 |
Ti-Largo Cervical Interbody System |
FloSpine |
Peter Harris |
| K230063 |
02/09/2023 |
G Surgical Marksman Spinal Deformity System |
G Surgical LLC |
Donald Grafton |
| K213755 |
02/17/2023 |
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K223439 |
02/13/2023 |
SIGNA Victor |
GE Healthcare (Tianjin) Company Limited |
Huande Li |
| K223832 |
02/16/2023 |
Vivid S60N, Vivid S70N |
GE Medical System Ultrasound and Primary Care Diagnostics |
Lee Bush |
| K223407 |
02/15/2023 |
Versana Essential |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Bush Lee |
| K220126 |
02/02/2023 |
Geonic Nasal Aspirator, Geonic Nasal Cleaner |
Geon Corporation |
Henry Chen |
| K221168 |
02/01/2023 |
Tinnitogram Signal Generator |
Goldenear Company, Inc. |
Daehee Lee |
| K222041 |
02/09/2023 |
CYGNUS-C Standalone ACIF System |
GS Medical Co. Ltd. |
Sam Camp |
| K223544 |
02/23/2023 |
LED light therapy mask (FM-01, FM-02, FM-03) |
Guangdong Newdermo Biotech Co.,Ltd |
Annie Cai |
| K221861 |
02/18/2023 |
FloNavi Endoscopic Fluorescence Imaging System |
Guangdong OptoMedic Technologies, Inc. |
Jane Guo |
| K221781 |
02/02/2023 |
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH |
Guangdong OptoMedic Technologies, Inc. |
Jane Guo |
| K230038 |
02/28/2023 |
MissLan« Pregnancy Rapid Test (Strip), MissLan« Pregnancy Rapid Test (Midstream) |
Guangzhou Decheng Biotechnology Co., Ltd. |
Weifang Liu |
| K222570 |
02/04/2023 |
COPAL knee moulds |
Heraeus Medical GmbH |
Alexander Peczka |
| K212635 |
02/13/2023 |
Sofjec |
Hwajin Medical Co.,Ltd. |
Jeon Sung Hun |
| K230208 |
02/22/2023 |
Swoop« Portable MR Imaging SystemÖ |
Hyperfine, Inc. |
Christine Kupchick |
| K222211 |
02/02/2023 |
Implant Direct Dental Implant Systems Portfolio - MR Conditional |
Implant Direct Sybron Manufacturing LLC |
Reina Choi |
| K221531 |
02/06/2023 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
Amnon Talmor |
| K221483 |
02/17/2023 |
FlowSaver Blood Return System |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| DEN220044 |
02/03/2023 |
Active Anthrax DetectTM Plus Rapid Test |
InBios International, Inc. |
Estela Raychaudhuri |
| K223330 |
02/01/2023 |
Certas Plus Programmable Valves |
Integra LifeSciences Production Corporation |
Amanda Erwin |
| K223051 |
02/03/2023 |
Pre-Formed Silicone Block |
International Medical Devices, Inc. |
Dr. James Elist |
| K222389 |
02/15/2023 |
ZEUS System |
iRhythm Technologies, Inc. |
Vishal Kanani |
| K230228 |
02/23/2023 |
Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) |
Iridex Corporation |
Mari Iwamoto |
| K223396 |
02/01/2023 |
Rapid RV/LV |
iSchema View Inc. |
James Rosa |
| K220505 |
02/09/2023 |
ATTIVA |
Italian Engineering srl |
Elisabetta Tonelli |
| K222588 |
02/17/2023 |
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 |
iWEECARE Co., Ltd. |
Julia Yang |
| K221694 |
02/09/2023 |
External Drainage System |
JMED(Shenzhen) Technology Limited |
Anna Xiao |
| K230245 |
02/28/2023 |
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System |
L&K BIOMED Co., Ltd. |
Katherine Kim |
| K213348 |
02/21/2023 |
BOND MMR Antibody Panel |
Leica Biosystems Newcastle, Ltd. |
Kristin Godfredsen |
| K213669 |
02/15/2023 |
LIGHTSCALPEL LS-4020 |
LightScalpel Inc |
David Walters |
| K223876 |
02/03/2023 |
SMR Shoulder System |
LimaCorporate S.p.A. |
Francesca Marello |
| K230339 |
02/24/2023 |
EsoCheck Cell Collection Device |
Lucid Diagnostics, Inc. |
Deepika Lakhani |
| K221452 |
02/10/2023 |
DiLumen C1, EZ1 and Tool Mount |
Lumendi, LLC |
Dennis Daniels |
| K222977 |
02/17/2023 |
DSPS-ProminentÖ Masks; DSPS-ProminentÖ Baseplate, MR; CouchStrip |
MacroMedics BV |
Elizabeth Hajos |
| K221253 |
02/03/2023 |
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K213757 |
02/14/2023 |
Endocem MTA Premixed Regular |
Maruchi |
SungWook Jang |
| K220035 |
02/27/2023 |
Milli Vaginal Dilator |
Materna Medical |
Kelly Ashfield |
| K223425 |
02/10/2023 |
MD.ai Viewer |
MDAI Inc |
Leon Chen |
| K221043 |
02/17/2023 |
Doctor Tecar Plus, Doctor Tecar Smart |
Mectronic Medicale S.r.l. |
Gloria Aloisini |
| K223582 |
02/24/2023 |
MectaLock TI Triple Loaded Suture Anchor |
Medacta International S.A. |
Stefano Baj |
| DEN210022 |
02/17/2023 |
PMD-200 |
Medasense Biometrics Ltd. |
Rachel Weissbrod |
| K223438 |
02/10/2023 |
TELIGEN System Peripheral Motor Nerve Stimulation Indications |
Medos International, SARL |
Daria Bochenek |
| K221784 |
02/16/2023 |
Single-use Video Pancreaticobiliary Scope, PB Digital Controller |
Micro-Tech (Nanjing) Co., Ltd |
Sally He |
| K223406 |
02/02/2023 |
SmartRelease Endoscopic Soft Tissue Release System |
MicroAire Surgical Instruments |
Glenn Gerstenfeld |
| K222153 |
02/03/2023 |
Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K221702 |
02/25/2023 |
CompuFlo Epidural Computer Controlled Anesthesia System |
Milestone Scientific, Inc. |
Arjan Haverhals |
| K223272 |
02/28/2023 |
SurBlate Ablation System |
Mima-Pro Scientific Inc. |
Jim Elliott |
| K223524 |
02/16/2023 |
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 |
MorLaser Shenzhen Co., Ltd. |
Janny Shao |
| K230197 |
02/22/2023 |
BoneMRI v1.6 |
MRIguidance B.V. |
Marijn Van Stralen |
| K223467 |
02/10/2023 |
Disposable Isolation Gown |
Nanning TECBOD Biological Technology Co.,Ltd. |
Bing Yao Chen |
| K223559 |
02/09/2023 |
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) |
Nephron Pharmaceuticals Corporation |
Lou Kennedy |
| K223797 |
02/23/2023 |
Neuro20 Pro System |
Neuro20 Technologies |
Dennis Schmitt |
| K221469 |
02/22/2023 |
PATI (Protector Against Tongue Injury) |
NeuroVice, LLC |
Ashlyn Sanders |
| K223627 |
02/02/2023 |
PreView-IIIÖ Anterior Cervical Plate System |
Nexus Spine, LLC |
Jared Crocker |
| K221472 |
02/08/2023 |
Filter and HME/Filter |
Ningbo Huakun Medical Equipment Co., Ltd. |
Lei Xi |
| K223026 |
02/03/2023 |
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter |
Northeast Scientific, Inc. |
Matt Farley |
| K213629 |
02/12/2023 |
SMILE |
Nu Eyne Co., Ltd. |
Dong Seong Lee |
| K222803 |
02/02/2023 |
Oncospace |
Oncospace, Inc. |
Sigrid Schoepel |
| K221527 |
02/14/2023 |
StitchKit |
Origami Surgical Inc . |
John Gillespie |
| K222063 |
02/03/2023 |
MONTAGE Settable, Resorbable Bone Putty |
Orthocon, Inc. |
Aniq Darr |
| K223761 |
02/13/2023 |
OIC Intramedullary Screw System |
Orthopaedic Implant Company |
Douglas Fulton |
| K223786 |
02/10/2023 |
Orthex External Fixation System |
OrthoPediatrics Corp. |
Yan Li |
| K230180 |
02/22/2023 |
Rosa Knee System |
Orthosoft, Inc (d/b/a Zimmer CAS) |
Kruti Gosalia |
| K223413 |
02/10/2023 |
PiscesÖ-SA STANDALONE ALIF Interbody System |
Osseus Fusion Systems |
Jonathan Rosen |
| K230201 |
02/22/2023 |
Disposable Pre-calibrated Brain Biopsy Needle 2.0 |
Pajunk GmbH Medizintechnologie |
Christian Quass |
| K220698 |
02/16/2023 |
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X |
Panthera AB |
Fredrik Stantz |
| K223056 |
02/16/2023 |
JAWS Nitinol Staple System |
Paragon 28, Inc. |
Haylie Hertz |
| K223186 |
02/13/2023 |
Indigo« Aspiration System û Lightning Bolt Aspiration Tubing |
Penumbra, Inc. |
Deanna Kimlinger |
| K221329 |
02/22/2023 |
Eyer Retinal Camera NM-STD |
Phelcom Technologies |
Flßvio Pascoal Vieira |
| K221348 |
02/03/2023 |
IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) |
Philips Medizin Systeme B÷blingen GmbH |
Stefan Breuer |
| K221474 |
02/10/2023 |
PRIMUS Healthcare Sterilizer (Model PSS11-HC) |
PRIMUS Sterilizer Company, LLC |
Patrick Hansen |
| K223798 |
02/17/2023 |
Glidewell TuffSplintÖ Appliance Resin |
Prismatik Dentalcraft, Inc. |
Jiahe Li |
| K222680 |
02/02/2023 |
DeltaScan Monitor |
Prolira B.V. |
Rutger O. van Merkerk |
| K222671 |
02/02/2023 |
DeltaScan Patch |
Prolira B.V. |
Rutger O. van Merkerk |
| K223643 |
02/21/2023 |
Verifine« Ease Lancing Device, Verifine« Lancing Device |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K222271 |
02/15/2023 |
Verisafe Safety sterile needles |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K221875 |
02/13/2023 |
Sterilization Pouch and Roll |
Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. |
Zhao Fusong |
| K223686 |
02/07/2023 |
Medical Protective Masks |
Qinhuangdao Taizhi Medical Technology Co., Ltd. |
Fan Xifan |
| K212587 |
02/22/2023 |
3D-RD-S |
Radiopharmaceutical Imaging and Dosimetry, LLC |
Nadine Bonds |
| K223612 |
02/21/2023 |
Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) |
Ranfac Corporation |
Eric Kreuz |
| K213480 |
02/01/2023 |
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil |
RAPID Biomedical GmbH |
Marius Berthel |
| K230059 |
02/03/2023 |
Digital Flat Panel Detector |
Ray Imaging Technology (Haining) Limited |
Jeffrey Wu |
| DEN220014 |
02/01/2023 |
RefleXion Medical Radiotherapy System (RMRS) |
RefleXion Medical Inc |
Kathy O'Shaughnessy |
| K230131 |
02/15/2023 |
ReShape Calibration Tubes |
ReShape Lifesciences |
Dov Gal |
| K223859 |
02/13/2023 |
Rhino Non-sterile Powder-Free Nitrile Exam Glove û Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl |
Rhino Health Inc. |
Mark Lee |
| K230212 |
02/23/2023 |
OrthoButton AL |
Riverpoint Medical, LLC |
Rebecca DeFrancia |
| K223444 |
02/06/2023 |
Powder Free Blue Nitrile Examination Glove |
S&S Glove Corporation |
Poppy Farrah Rossa |
| K221741 |
02/22/2023 |
TRAUS Air Dental Handpiece |
Saeshin Precision Co., Ltd. |
Gung San Nam |
| K223387 |
02/13/2023 |
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ju Jee Young |
| K222173 |
02/27/2023 |
Saneso Lens Wash Bottle Assembly (SAN-LWB-A) |
Saneso, Inc. |
Nitesh Ratnakar |
| K223116 |
02/28/2023 |
8X-10-6XXX Camera Head |
Santa Barbara Imaging Systems |
Jim Candy |
| K223810 |
02/24/2023 |
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) |
SB-Kawasumi Laboratories, Inc. |
Shiro Agehama |
| K221591 |
02/23/2023 |
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source |
Schoelly Fiberoptic GmbH |
Sandra Baumann |
| K220296 |
02/03/2023 |
Manta Ray TDF Spacer |
SeaSpine Orthopedics Corporation |
Kavita Chandrashekar |
| K220435 |
02/10/2023 |
SEJONG Surgical Gown Soft |
Sejong Healthcare Co., Ltd. |
Bong Sung Lee |
| K230241 |
02/23/2023 |
Jumong General |
SG Healthcare CO LTD |
Byung Ju Kang |
| K223298 |
02/22/2023 |
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) |
Shandong Intco Medical Products Co, Ltd. |
Min Gao |
| K223327 |
02/16/2023 |
Sterile Aesthetic Cannula and Hypodermic Needle |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Liu Hualong |
| K223678 |
02/09/2023 |
Sterile Syringes for Single Use |
Shanghai Kindly Enterprise Development Group Co., Ltd. |
Amy Li |
| K220214 |
02/18/2023 |
Painless IPL System - KDT750 |
Shanghai Omni Laser Skinology Co., Ltd. |
Avril Ouyang |
| K223028 |
02/16/2023 |
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K222755 |
02/16/2023 |
uMR 680 |
Shanghai United Imaging Intelligence Co., Ltd. |
Xin GAO |
| K222928 |
02/07/2023 |
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9 |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
Zhang Wei |
| K223225 |
02/14/2023 |
8ch T/R Knee Coil |
Shenzhen RF Tech Co., Ltd. |
Gary Wang |
| K223618 |
02/28/2023 |
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD |
Shenzhen Ulike Smart Electronics Co.,Ltd |
Shane Xie |
| K213431 |
02/26/2023 |
Handheld Pulse Oximeter |
Shenzhen Witleaf Medical Electronics Co.,Ltd |
Wu Tao |
| K223194 |
02/10/2023 |
Glass Ceramic |
Shenzhen Xiangtong Co.,Ltd. |
Xue Gong |
| K223395 |
02/03/2023 |
Luna Dental Implant System |
Shinhung MST Co., Ltd |
Sun Ho Lee |
| K230196 |
02/13/2023 |
syngo.via View&GO VA40A |
Siemens Healthcare GmBH |
Frederike Jakob |
| K223735 |
02/06/2023 |
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K230207 |
02/13/2023 |
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K213805 |
02/24/2023 |
MAGNETOM Vida |
Siemens Medical Solutions USA, Inc. |
Karthik Pillai |
| K222574 |
02/04/2023 |
Simparo Anchor Line Fixation System |
Simparo, Inc. |
Chris Harber |
| K223022 |
02/15/2023 |
SC HONKYTONK PTCA Balloon Dilatation Catheter |
Sino Medical Sciences Technology Inc. |
Jianhua Sun |
| K222971 |
02/17/2023 |
ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device |
Smith & Nephew Inc |
Dongeun LoPresti |
| K213853 |
02/10/2023 |
RENASYSÖ-WF White Foam NPWT Dressing Small; RENASYSÖ-WF White Foam NPWT Dressing Large |
Smith and Nephew Medical Limited |
Jean-Marie Steeve |
| K222596 |
02/10/2023 |
S90 Exp Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K222422 |
02/02/2023 |
Polaris Valve Electronic Reading Instrument |
Sophysa |
Philippe Negre |
| K221257 |
02/28/2023 |
SpectraWAVE Imaging System |
SpectraWAVE Inc |
Farzad Parsaie |
| K223497 |
02/17/2023 |
Spectrum Saliva Collection Device |
Spectrum Solutions, LLC |
Katie Compton |
| K223815 |
02/15/2023 |
ONE DROP Lancing Device |
STAT Medical Devices |
Hemel Mariano |
| K213545 |
02/02/2023 |
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 |
Steelco S.P.A. |
Veronica Basso |
| K223466 |
02/17/2023 |
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 |
Steris Corporation |
Carroll Martin |
| K221559 |
02/23/2023 |
Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 |
StringKing |
Thomas Frasca |
| K230216 |
02/23/2023 |
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) |
Stryker |
Michelle Stephens |
| K223770 |
02/16/2023 |
Sonopet 1Q 3 7cm 1Q Large |
Stryker Corporation |
Thomas Flannelly |
| K212194 |
02/16/2023 |
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precisi |
Stryker Corporation |
Bryan K. Hann |
| K223767 |
02/13/2023 |
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System |
Stryker Leibinger GmbH & Co. KG |
Megan B Guilbault |
| K221490 |
02/14/2023 |
Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement Syste |
Stryker Spine |
Renee Norby |
| K223492 |
02/22/2023 |
eFOLDi Scooter, Lite |
SunTech UK Ltd. |
Sumi Wang |
| K222240 |
02/28/2023 |
EXPLORER AIR« II |
SurgVision GmbH |
Daniela Mahan |
| K223208 |
02/10/2023 |
Safety Lancet |
Suzhou Zhenwu Medical Co., Ltd. |
Kai Xu |
| K223680 |
02/10/2023 |
Eneka Pro |
TermoSalud |
Cristina Cifuentes Pantoja |
| K221641 |
02/28/2023 |
Terragene« Bionova« Hyper Biological Indicator (BT98), Terragene« Bionova« Hyper Auto-reader Incubator (BHY), Terragene« Bionova« NanoBio Auto-reader Incubator (BNB) |
Terragene SA |
Hernando Carrizo |
| K223169 |
02/06/2023 |
Nerivio |
Theranica Bioelectronics ltd |
Alon Ironi |
| K222259 |
02/21/2023 |
NEONA 1.5T MRI System |
Time Medical Limited |
Nick Tse |
| K222863 |
02/01/2023 |
Garment Electrodes |
Tone-A-Matic International Inc. |
Manuel Chuck |
| K222129 |
02/10/2023 |
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim |
Top Glove Medical (Thailand) Co., Ltd. |
Shahana Parveen Binti Ridzam Shah |
| K230089 |
02/09/2023 |
ETHICON LINX« Esophagus Sizing Tool |
Torax Medical Inc. |
Brian Godwin |
| K220276 |
02/17/2023 |
Infrared Thermometer TET-351 |
Truly Instrument Limited |
LiuJin Ting |
| K223216 |
02/23/2023 |
Symphony Thrombectomy System |
Truvic Medical Inc. |
Vida Sollanek |
| K221614 |
02/24/2023 |
TytoCare Lung Sounds Analyzer |
Tyto Care Ltd. |
Stella Raizelman Perry |
| K221523 |
02/15/2023 |
Tanning Lamp |
Unilam Co., Ltd. |
Y B Cho |
| K221705 |
02/28/2023 |
U2 Total Knee System-PF+ |
United Orthopedic Corporation |
Lois Ho |
| K230248 |
02/28/2023 |
VIOLA |
Vascular Graft Solutions, Ltd. |
Orit Yarden |
| K222386 |
02/24/2023 |
Visionbody |
VB Technologies AG |
Jorge Millan |
| K223296 |
02/06/2023 |
Videa Perio Assist |
VideaHealth, Inc. |
Adam Foresman |
| K222398 |
02/06/2023 |
Care Team Portal |
Vivify Health, Inc. |
Tracey Fox |
| K223392 |
02/28/2023 |
REVCON (TM) Screw System |
Voom Medical Devices, Inc. |
Neal M Blitz |
| K223852 |
02/24/2023 |
VySpanÖ PCT System |
Vy Spine, LLC |
Jordan Hendrickson |
| K221356 |
02/02/2023 |
Wee Bell |
wee MEDICAL |
D Preston Smith |
| K223075 |
02/27/2023 |
Ogmend« Implant Enhancement System |
Woven Orthopedic Technologies |
Brandon Bendes |
| K221645 |
02/17/2023 |
PROstep(TM) MIS 5mm Chamfer Screw System |
Wright Medical Technology |
Anna Bushart |
| K221476 |
02/10/2023 |
Perifit |
X6 Innovations |
Artem Rodionov |
| K222955 |
02/06/2023 |
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard |
Xenta Biomedical Science Co., Ltd. |
Huang Ling |
| K223304 |
02/08/2023 |
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) |
Xiamen Probtain Medical Technology Co., Ltd |
Jianli Kang |
| K222751 |
02/01/2023 |
LED Light Therapy Device, KN-7000L |
Xuzhou Kernel Medical Equipment Co., Ltd. |
Cuiling Xi |
| K222513 |
02/10/2023 |
Glass Ceramics |
Yilink (Tianjin) Biotechnology Co., Ltd |
Yaqiong Zhu |
| K213891 |
02/24/2023 |
RealNow |
YIWEI Medical Technology Co., Ltd |
Eric Ke |
| K222507 |
02/28/2023 |
Mobility Scooter (Models: W3431Q, W3431R) |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
Leo Zheng |
| K220657 |
02/10/2023 |
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) |
Zhejiang Rongsheng Industrial Co., Ltd. |
Wu Bentuan |
