| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K231585 |
05/31/2023 |
Vantage PSI System |
3D Systems, Inc. |
Ashley Dawson |
| K231464 |
05/19/2023 |
3MÖ ClarityÖ Aligners (3MÖ ClarityÖ Aligners-Force, 3MÖ ClarityÖ Aligners-Flex) |
3M Company, Unitek Orthodontic Products |
Brittany Randolph |
| K231338 |
05/08/2023 |
3MÖ ClinproÖ Clear 2.1% Sodium Fluoride Treatment |
3M ESPE Dental Products |
Chandrapaul Parsram |
| K231311 |
05/05/2023 |
CPS DirectÖ Universal slittable outer guide catheter (DS2C029) |
Abbott Medical |
Mary Adams |
| K231415 |
05/16/2023 |
EnSiteÖ X EP System |
Abbott Medical |
Alyssa Timmers |
| K231279 |
05/03/2023 |
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm |
Ablative Solutions, Inc. |
Kristine Canavan |
| K231293 |
05/04/2023 |
DrakonÖ and Sequre« Microcatheters |
Accurate Medical Therapeutics |
Osnat Harbater |
| K231509 |
05/25/2023 |
Aco Apache Ultrasound System |
Aco Healthcare Co., Ltd. |
Henry Huang |
| K231532 |
05/26/2023 |
ActiGraph LEAP activity monitor (ActiGraph LEAP) |
ActiGraph, LLC |
Brian Bell |
| K231344 |
05/09/2023 |
ActivSight Intraoperative Imaging System |
Activ Surgical Inc. |
Nicholas Child |
| K231254 |
05/01/2023 |
GripTract-GI Endoscopic Tissue Manipulator |
Actuated Medical, Inc. |
Douglas R. Dillon |
| K231337 |
05/08/2023 |
EndeavorRx |
Akili Interactive Labs, Inc. |
Bhupinder Singh |
| K231298 |
05/04/2023 |
Ultravision2Ö System Integrated Monopolar L-Hook (H/S)Ö |
Alesi Surgical Ltd. |
Dominic Griffiths |
| K231438 |
05/17/2023 |
Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System |
Alphatec Spine, Inc. |
Unnati Bhuptani |
| K231261 |
05/01/2023 |
Altaviz Needle Kit II |
Altaviz, LLC |
James Lescoulie |
| K231365 |
05/11/2023 |
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves |
Anhui Intco Medical Products Co., Ltd |
Max li |
| K231384 |
05/12/2023 |
Annalise Enterprise CTB Triage Trauma |
Annalise-AI Pty Ltd. |
Haylee Bosshard |
| K231553 |
05/30/2023 |
OverStitch NXT Endoscopic Suturing System |
Apollo Endosurgery Inc. |
James Shene |
| K231305 |
05/05/2023 |
Endoform Dental Membrane |
Aroa Biosurgery Ltd. |
Tina O'Brien |
| K231575 |
05/31/2023 |
Vecttor VT-300 |
Artaflex Inc. |
Gerry Iuliano |
| K231353 |
05/10/2023 |
AccuCTP Pro |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K231330 |
05/08/2023 |
FiberTak« Suture Anchor |
Arthrex Inc. |
Erikka Edwardsen |
| K231323 |
05/08/2023 |
Ancora-SB |
Aspero Medical, Inc. |
Mark Rentschler |
| K231473 |
05/22/2023 |
Monarch Bronchoscope |
Auris Health Inc., a Johnson and Johnson Family Company |
Somi Ekwealor |
| K231536 |
05/30/2023 |
eQUANT System |
Avails Medical, Inc. |
Meike Herget |
| K231456 |
05/19/2023 |
Avitus« DragonWing Large Volume Autograft Delivery System |
Avitus Orthopaedics, Inc. |
Maxim Budyansky |
| K231242 |
05/01/2023 |
Perifix FX Catheter; Contiplex FX Catheter |
B. Braun Medical Inc. |
Tracy Larish |
| K231283 |
05/03/2023 |
SiteRiteÖ 9 Ultrasound System |
Bard Access Systems, Inc. (C.R. Bard, Inc.) |
Fabio De Pasquale |
| K231373 |
05/12/2023 |
BD Vacutainer« K2 EDTA Blood Collection Tubes |
Becton Dickinson and Company |
Pablo Martinez |
| K231318 |
05/08/2023 |
Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) |
Beijing ADSS Development Co., Ltd. |
Song Ying |
| K231513 |
05/25/2023 |
Oral Matrix |
Beijing Biosis Healing Biological Technology Co., Ltd. |
Ting Jiang |
| K231354 |
05/10/2023 |
Pocket Ultrasound System (C10) |
Beijing Konted Medical Technology Co., Ltd. |
Deyi Zhu |
| K231406 |
05/15/2023 |
ClearumTM HS |
Bellco Srl |
Rekha Roveri |
| K231368 |
05/11/2023 |
Bemer Therapy System Evo |
Bemer INT AG |
Sandra Schwarzenberger |
| K231485 |
05/23/2023 |
iLet« ACE Pump |
Beta Bionics, Inc. |
Liz Cooper |
| K231567 |
05/31/2023 |
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K231340 |
05/09/2023 |
Renova Spine Balloon Catheter |
Biopsybell s.r.l. |
Carlo Ricca Prandi Bellini |
| K231312 |
05/05/2023 |
PENTARAY« NAV ECO High Density Mapping Catheter, DECANAV« Mapping Catheter, Webster« CS Catheter with Auto ID, Webster« CS Catheter with EZ Steer Technology, Webster« CS Catheter with EZ Steer Technology with Auto ID |
Biosense Webster Inc. |
Caleb Lau |
| K231412 |
05/16/2023 |
CARTO VIZIGO« 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) |
Biosense Webster, Inc. |
Caleb Lau |
| K231366 |
05/11/2023 |
Neuronaute Plus |
BioSerenity SAS |
Madubuike Okafor |
| K231314 |
05/05/2023 |
Fine OsteotomyÖ |
BodyCad Laboratories, Inc. |
Nadine Adia |
| K231528 |
05/26/2023 |
Bonalive Orthopedics granules |
Bonalive Biomaterials, Ltd. |
Kristoffer Sibelius |
| K231292 |
05/04/2023 |
TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System |
Bonebridge AG |
Michelle Gumpelmayer |
| K231328 |
05/08/2023 |
LUX-Dx II (M302); LUX-Dx II+ (M312) |
Boston Scientific Corp |
Melissa Klamerus |
| K231549 |
05/30/2023 |
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System |
Boston Scientific Corporation |
Jotham Moon |
| K231533 |
05/26/2023 |
Habib EndoHPB |
Boston Scientific Corporation |
Carter Navarro |
| K231498 |
05/24/2023 |
TraumaCad Neo |
Brainlab Ltd. |
Yael Guttentag |
| K231299 |
05/04/2023 |
Nutricair enteral ENFit adapter: ENFit male û stepped/Christmas tree connector |
Cair LGL |
Irving L Wiesen |
| K231300 |
05/04/2023 |
Nutricair Enteral Syringe with ENFit |
Cair LGL |
Irving L. Wiesen, Esq. |
| K231281 |
05/03/2023 |
Aquilion Serve (TSX-307A/1) V1.3 |
Canon Medical Systems Corporation |
Paul Biggins |
| K231280 |
05/03/2023 |
CarboClear« X Pedicle Screw System; CarboClear« X Navigated Instruments; CarboClear« X Fenestrated Pedicle Screw System with High V+« Bone Cement |
Carbofix Orthopedics Ltd. |
Yael Rubin |
| K231538 |
05/30/2023 |
FreedomFlow Orbital Circumferential Atherectomy System |
Cardio Flow, Inc. |
Michael J. Kallok |
| K231256 |
05/01/2023 |
Carecube Negative Pressure Isolation Chamber |
Carecubes, Inc. |
Alexander Laskey |
| K231381 |
05/12/2023 |
Xpert Xpress MVP; GeneXpert Xpress System |
Cepheid |
Suzette Chance |
| K231481 |
05/23/2023 |
Xpert Xpress CoV-2/Flu/RSV plus |
Cepheid« |
Suzette Chance |
| K231414 |
05/16/2023 |
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) |
Chalice Medical Ltd |
Stephen Horan |
| K231335 |
05/08/2023 |
Cleerly ISCHEMIA |
Cleerly, Inc |
Candice Bautista-Biddle |
| K231576 |
05/31/2023 |
cNeuro cPET |
Combinostics Oy |
Thurfjell Lennart |
| K231546 |
05/30/2023 |
Somfit |
Compumedics Limited |
Michael Frischman |
| K231494 |
05/23/2023 |
CoreLink Robotic Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K231491 |
05/23/2023 |
TAÖ Stapler and Loading Unit with DST SeriesÖ Technology |
Covidien |
Emily Jacobs |
| K231411 |
05/16/2023 |
INNO SLA Submerged Hybrid Ti-Base System |
Cowellmedi Co., Ltd. |
Haejun Lee |
| K231395 |
05/15/2023 |
INNO SLA Submerged Narrow Implant System |
Cowellmedi Co., Ltd. |
Haejun Lee |
| K231359 |
05/10/2023 |
RODINÖ Expandable Lumbar Cage System |
CTL Medical Corporation |
Sean Suh |
| K231506 |
05/24/2023 |
Current Health System |
Current Health Ltd |
Giovanni Maggi |
| K231514 |
05/25/2023 |
Azure |
Daeshin Enterprise Co., Ltd. |
Kyu Kim |
| K231437 |
05/17/2023 |
LF900 |
Daesung Maref Co., Ltd |
Su Hyeon So |
| K231324 |
05/08/2023 |
DASI Dimensions (V1.0) |
DASI Simulations |
Sri Krishna Sivakumar |
| DEN230035 |
05/04/2023 |
DentalMonitoring |
Dental Monitoring SAS |
Isabelle Puraye |
| K231578 |
05/31/2023 |
Lucitone Digital Print Denture System |
Dentsply Sirona |
Rebecca Sporer |
| K231526 |
05/26/2023 |
CORAIL Cemented Femoral Stem |
DePuy Ireland UC |
Amy Joyce |
| K231522 |
05/26/2023 |
EMPHASYSÖ Dual Mobility System |
DePuy Ireland UC |
Farah Valli |
| K231516 |
05/25/2023 |
INHANCEÖ Shoulder System, Sterile Single Use Instrumentation |
Depuy Ireland UC |
Yayoi Fujimaki |
| K231503 |
05/24/2023 |
CUPTIMIZEÖ Advanced |
DePuy Orthopaedics, Inc |
Sierra Robinson |
| K231552 |
05/30/2023 |
Dia-Cem |
Diadent Group International |
Kab Sun Lee |
| K231360 |
05/10/2023 |
Ambra PACS |
DICOM Grid dba Ambra Health |
Ashley Brown |
| K231264 |
05/02/2023 |
Easy On Universal Glaze & Stain |
Doctus Global |
Beom-jin Choi |
| K231370 |
05/12/2023 |
Dewin Blastocyst Medium (with HSA and without HSA) |
DonneVie Medical Technology (Shanghai) Co. Ltd. |
Hannah Hang Yin |
| K231573 |
05/31/2023 |
ThinkQA (Edition 2) |
DOSIsoft SA |
Marc Uszynski |
| K231477 |
05/22/2023 |
Infinity CentralStation Wide, Infinity M300, Infinity M300+ |
Draeger Medical Systems, Inc. |
Deborah Herrington |
| K231277 |
05/03/2023 |
TissueStat |
DuraStat LLC |
Adam Azzara |
| K231248 |
05/01/2023 |
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform |
Edwards Lifesciencess LLC |
Anne Lo |
| K231309 |
05/05/2023 |
SCAR 3 |
El.en Electroinc Engineering Spa |
Paolo Peruzzi |
| K231307 |
05/05/2023 |
Elos Accurate Customized Abutment |
Elos Medtech Pinol A/S |
Lise Terkelsen |
| K231586 |
05/31/2023 |
Endophys Blood Pressure Monitor model BPM-30 |
Endophys Technologies LLC |
Zachary Sowell |
| K231355 |
05/10/2023 |
Aurora |
EnsoData |
Sigrid Schoepel |
| K231409 |
05/15/2023 |
Erchonia FX-405 |
Erchonia Corporation |
Travis Sammons |
| K231474 |
05/22/2023 |
Erchonia Violet ZERONA« Z6 OTC |
Erchonia Corporation |
Travis Sammons |
| K231403 |
05/15/2023 |
evoDrill Cranial Perforator |
Evonos GmbH & Co. KG |
J÷rg Mans |
| K231410 |
05/15/2023 |
RenaPure Endotoxin Retentive Filter |
Evoqua Water Technologies LLC |
Robert Dudek |
| K231267 |
05/02/2023 |
ClearTip |
Finemedix Co., Ltd. |
Seok-Jun Ma |
| K231297 |
05/04/2023 |
Firstar Dental Unit |
Firstar Dental Company |
Kang N Lei |
| K231446 |
05/18/2023 |
Single-Use Latex Sterile Surgical Gloves (SG100) |
Fitone Latex Products Co., Ltd. Guangdong |
Christine Ou |
| K231534 |
05/30/2023 |
5008X Hemodialysis System |
Fresenius Medical Care |
Denise M Oppermann |
| K231574 |
05/31/2023 |
Scenaria View 4.2 |
Fujifilm Healthcare Americas Corporation |
Chaitrali Kulkarni |
| K231531 |
05/26/2023 |
PediarityÖ |
Gabi SmartCare SA |
Edouard Carton |
| K231301 |
05/05/2023 |
Vscan Air |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Bush Lee |
| K231480 |
05/22/2023 |
Bright MTA Sealer Plus |
Genoss Co., Ltd. |
Boram Choi |
| K231333 |
05/08/2023 |
STRETTOÖ Cable System |
Globus Medical Inc. |
Jennifer Antonacci |
| K231250 |
05/01/2023 |
Digital Blood Pressure Monitor |
Guangdong Genial Technology Co., Ltd. |
Yu Jun |
| K231245 |
05/01/2023 |
Digital Blood Pressure Monitor (Arm Type) |
Guangdong Genial Technology Co., Ltd. |
Yu Jun |
| K231243 |
05/01/2023 |
Finger Clip Pulse Oximeter |
Guangdong Genial Technology Co., Ltd. |
Yu Jun |
| K231342 |
05/09/2023 |
Insufflator (OPTO-IFL1000) |
Guangdong OptoMedic Technologies, Inc. |
Weijuan Guo |
| K231561 |
05/31/2023 |
Pulmonary Function Tester, Model: A9 |
Guangzhou Homesun Medical Technology Co., Ltd |
Suijie Huang |
| K231327 |
05/08/2023 |
POWERSEAL Sealer and Divider |
Gyrus ACMI, Inc. |
Dolan Mills |
| K231363 |
05/11/2023 |
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) |
Hantech Medical Device Co., Ltd. |
Arnold Yang |
| K231568 |
05/31/2023 |
HardyDisk AST Sulbactam/Durlobactam 10/10╡g (SUD20) |
Hardy Diagnostics |
Anna Klavins |
| K231389 |
05/12/2023 |
Harvest Dental HD Gum Strip |
Harvest Dental Products, LLC |
Colleen Boswell |
| K231404 |
05/15/2023 |
T-Button« A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button« S Adjustable Loop UHMWPE Suture PEEK Button, Open Button |
Healthium Medtech Limited |
Pankaj Dawar |
| K231424 |
05/17/2023 |
HeartBeam AIMIGo(TM) System |
HeartBeam, Inc. |
Ken Persen |
| K231545 |
05/30/2023 |
hearOAE |
hearX SA (Pty) Ltd |
Seline Van Der Wat |
| K231329 |
05/08/2023 |
Aptima Neisseria gonorrhoeae Assay |
Hologic, Inc. |
Jon Kukowski |
| K231316 |
05/08/2023 |
Aptima Trichomonas vaginalis Assay |
Hologic, Inc. |
Jingwen Chen |
| K231426 |
05/17/2023 |
8plant Implant System |
Hoowon EDI Co., Ltd |
Jihun Choi |
| K231429 |
05/17/2023 |
S-Plant Dental Implant System |
IDIS Co., Ltd. |
Aiden Lee |
| K231455 |
05/18/2023 |
Implant-One System |
Implant Logistics, Inc. |
Thomas Arendt |
| K231413 |
05/16/2023 |
IPD Dental Implant Abutments |
Implant Protesis Dental 2004 S.L. |
Francesc Fumanal |
| K231495 |
05/23/2023 |
The Evolve System with the Transform Applicator |
InMode Ltd. |
Suhair Francis |
| K231259 |
05/01/2023 |
iRoot SP Plus |
Innovative BioCeramix, Inc. |
Quanzu Yang |
| K231378 |
05/12/2023 |
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 |
Insightec, Ltd. |
Inbal Ben Tzvi |
| K231358 |
05/10/2023 |
Universal Seal (5-12 mm) |
Intuitive Surgical, Inc. |
Emily Hovick |
| K231555 |
05/30/2023 |
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) |
iSMART Developments Ltd |
Susan D'Arcy |
| K231557 |
05/30/2023 |
ZENEX FreeMilling & CCM Cast Abutment |
Izenimplant Co., Ltd. |
Ji-Hwan Jeong |
| K231441 |
05/18/2023 |
ARIX Ankle System |
Jeil Medical Corporation |
Dajung Lee |
| K231251 |
05/01/2023 |
FlexWing Anterior Cervical Plate System |
Jeil Medical Corporation |
Sejin Ryu |
| K231287 |
05/04/2023 |
POTENZA |
Jeisys Medical Inc. |
Bora Kim |
| K231405 |
05/15/2023 |
Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode |
Jiangsu Rong Fu Kang Medical Instruments Co., Ltd. |
Steve Livneh |
| K231303 |
05/05/2023 |
Arm-type Fully Automatic Digital Blood Pressure Monitor |
Joytech Healthcare Co., Ltd |
Ren Yunhua |
| K231460 |
05/19/2023 |
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUMÖ & BALTEUM-ONEÖ Lumbar Plate System, and OspreyÖ Anterior Cervical Plate System |
K&J Consulting Corp. |
Jeena Mathai |
| K231435 |
05/17/2023 |
KIMTECHÖ PolarisÖ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
Kimberly-Clark Corporation |
Kimberly Tempas |
| K231402 |
05/15/2023 |
HP PTA Balloon Dilatation Catheter |
Kossel Medtech (Suzhou) Co.,Ltd. |
Ron Lv |
| K231282 |
05/03/2023 |
LifeOutcomes C-QuestÖ Blood Culture Sampling Device |
LifeOutcomes LLC |
Robert J. McKinnon |
| K231422 |
05/17/2023 |
Precision GI |
Limaca Medical Ltd |
Assaf Klein |
| K231387 |
05/12/2023 |
Endofill |
Lumendo AG |
Mark Bispinghoff |
| K231470 |
05/22/2023 |
Lunit INSIGHT DBT |
Lunit Inc. |
Hyung Tak Han |
| K231393 |
05/12/2023 |
Radical the Dude 7F Guide Catheter |
Maduro Medical, Inc. |
Janice Kemp |
| K231569 |
05/31/2023 |
ManaFlexx 2 (model: MF002-RX, MF002-OTC) |
ManaMed, Inc |
Trevor Theriot |
| K231391 |
05/12/2023 |
Combi Touch |
Mectron S.p.A. |
Edoardo Tronchet |
| K231515 |
05/25/2023 |
MySpine Cervical Guides |
Medacta International S.A. |
Stefano Baj |
| K231483 |
05/23/2023 |
MySpine Unilateral Guides |
Medacta International S.A. |
Stefano Baj |
| K231566 |
05/31/2023 |
ICX-Implant System |
Medentis Medical GmbH |
Alexander Scholz |
| K231418 |
05/16/2023 |
ENDOGATORÖ Hybrid Irrigation Tubing |
Medivators |
Disha Kabrawala |
| K231527 |
05/26/2023 |
TriALTIS Navigation Enabled Instruments |
Medos International S└RL |
Nicole Aeschbacher |
| K231479 |
05/22/2023 |
TriALTIS Spine System |
Medos International SARL |
Megan Smith |
| K231580 |
05/31/2023 |
NIMÖ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) |
Medtronic Xomed, Inc. |
Alexandra Oliver |
| K231468 |
05/22/2023 |
SCOUT MD Surgical Guidance System |
Merit Medical System, Inc. |
Saboo Sandeep |
| K231246 |
05/01/2023 |
VentraxÖ Delivery System (VTR851) |
Merit Medical Systems, Inc. |
Jenny Soderquist |
| K231562 |
05/31/2023 |
ELEC ENGINE (Model: ISE-170L) |
Micro-NX Co., Ltd. |
Lee Jong Kun |
| K231579 |
05/31/2023 |
MOLLI 2 |
MOLLI Surgical, Inc. |
Joseph De Croos |
| K231274 |
05/02/2023 |
Natural Cycles |
Natural Cycles Nordic AB |
Raoul Scherwitzl, PhD |
| K231392 |
05/12/2023 |
NaviNetics Reusable Stereotactic System (NN1000) |
NaviNetics Inc. |
Danielle Jondal |
| K231349 |
05/09/2023 |
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) |
Nephron Nitrile, LLC. |
Lou Kennedy |
| K231350 |
05/09/2023 |
OCD MT Cap (85-00397-000) |
Neuronetics |
Amanda Pentecost |
| K231486 |
05/23/2023 |
Stable-L Standalone Lumbar Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K231371 |
05/12/2023 |
BEE Cervical Cage |
NGMedical GmbH |
Stella Hahn |
| K231570 |
05/31/2023 |
StrokeViewer Perfusion |
NICo-Lab B.V. |
Veronica Padharia |
| K231449 |
05/18/2023 |
Portable X-ray System Model Ray98(P) |
Ningbo Runyes Medical Instrument Co., Ltd. |
Weiqiong Fang |
| K231255 |
05/01/2023 |
NovoFine« Plus |
Novo Nordisk Inc. |
Hiral Palkhiwala Shah |
| K231416 |
05/16/2023 |
Air Next (NVD-02) |
NuvoAir AB |
Furat Shawki |
| K231453 |
05/18/2023 |
SnapHammer Hammertoe Correction System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K231284 |
05/03/2023 |
OnPoint Augmented Reality Spine System |
OnPoint Surgical, Inc. |
Amy ODonnell |
| K231396 |
05/15/2023 |
CEPHX- Cephalometric Analysis Software |
Orca Dental AI LTD |
Daniel Abraham |
| K231525 |
05/26/2023 |
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack |
Ortho Clinical Diagnostics |
Declan Hynes |
| K231517 |
05/25/2023 |
VITROS Immunodiagnostic Products CEA Reagent Pack |
Ortho Clinical Diagnostics |
Rebecca Lewis |
| K231270 |
05/02/2023 |
Montage Flowable Settable, Resorbable Bone Paste |
Orthocon, Inc. |
Aniq Darr |
| K231386 |
05/12/2023 |
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste |
Orthocon, Inc. |
Aniq Darr |
| K231475 |
05/22/2023 |
MONTAGE-QS Settable, Resorbable Bone Putty |
Orthocon, Inc. |
Aniq Darr |
| K231266 |
05/02/2023 |
Pediatric Nailing Platform Tibia |
OrthoPediatrics Corp. |
Yan Li |
| K231272 |
05/02/2023 |
OSSIOfiber« Pin Product Family, OSSIOfiber« Compression Screw, OSSIOfiber« Trimmable Fixation Nail |
OSSIO Ltd. |
Taly Lindner |
| K231443 |
05/18/2023 |
Mini-OSTEO Pedicle Fixation System |
OSTEOMED Ind·stria e ComΘrcio de Implantes LTDA |
Fernando Argenton Neto |
| K231326 |
05/08/2023 |
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) |
Osteonic Co., Ltd. |
Da Kyung Ham |
| K231322 |
05/08/2023 |
Fix2Lock(PEEK Self Punching) |
Osteonic Co., Ltd. |
Da Kyung Ham |
| K231556 |
05/30/2023 |
SPECTRUM« GV Bone Cement |
OsteoRemedies, LLC |
Eric Stookey |
| K231253 |
05/01/2023 |
Overture Orthopaedics Patellofemoral System |
Overture Resurfacing Inc. |
Riley Williams |
| K231496 |
05/24/2023 |
TITAN 3-D Wedge System |
Paragon 28 Inc |
Haylie Hertz |
| K231249 |
05/01/2023 |
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL |
PENTAX of America, Inc. |
William Goeller |
| K231539 |
05/30/2023 |
pRESET LITE Thrombectomy Device |
phenox Limited |
Rachel McDaid |
| K231430 |
05/17/2023 |
Intimate Rose Vaginal Dilators |
Plus EV Holdings dba Intimate Rose |
Aaron Wilt |
| K231401 |
05/15/2023 |
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva |
Poly Medicure Limited |
Ramdas Sharma |
| K231469 |
05/22/2023 |
PAXgene« Blood DNA Tube |
PreAnalytiX GmbH |
Alexandra Kirby |
| K231407 |
05/15/2023 |
StarFin |
Premium Medical Technology LLC |
Kuowei Chang |
| DEN230036 |
05/05/2023 |
Sepsis ImmunoScore |
Prenosis, Inc. |
Bobby Reddy |
| K231263 |
05/02/2023 |
Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT |
Prevest Denpro Limited |
Atul Modi |
| K231347 |
05/09/2023 |
BruxZirÖ TintEFX Coloring Liquid |
Prismatik Dentalcraft, Inc. |
Nina Chiang |
| K231529 |
05/26/2023 |
CloudPoint FastDesign Chairside |
Prismatik Dentalcraft, Inc. |
Jiahe Li |
| K231502 |
05/24/2023 |
Mini Screws |
Proimtech Saglik Urunleri Anonim Sirketi |
Hakan Cevik |
| K231484 |
05/23/2023 |
PureWay 1.4 Quart Sharps Collector |
PureWay Compliance Inc. |
Jeffery Miglicco |
| K231465 |
05/19/2023 |
Q-Pad Test System |
Qurasense |
Sara Naseri |
| K231467 |
05/22/2023 |
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF |
Rayence Co., Ltd |
Kevin Kim |
| K231459 |
05/19/2023 |
HepaFatSmart (V2.0.0) |
Resonance Health Analysis Services Pty Ltd |
Mitchell Wells |
| K231313 |
05/05/2023 |
Therapy Mask 3100 NC/SP |
Respironics Inc. |
Shipra Gulati |
| K231458 |
05/19/2023 |
Extremity Staple |
restor3d |
Anika Moorjani |
| K231519 |
05/25/2023 |
Revital Cady |
Revital Healthcare (EPZ) Limited |
Ankur Vora |
| K231291 |
05/04/2023 |
Perforated Baskets |
Richard Wolf Medical Instruments Corporation |
Mike McAndrew |
| K231278 |
05/03/2023 |
Knotless Suture Anchor |
Riverpoint Medical, LLC |
Bianca Silva de Sousa |
| K231348 |
05/09/2023 |
Elecsys ▀-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF |
Roche Diagnostics |
Greg Mondics |
| K231306 |
05/05/2023 |
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems |
Roche Molecular Systems, Inc. |
Caroline Sobek |
| K231385 |
05/12/2023 |
Rology Teleradiology Platform (v.1.22.1103) |
Rology Inc. |
Amr Abodraiaa |
| K231583 |
05/31/2023 |
Route 92 Medical Full Length 054 Access System |
Route 92 Medical, Inc. |
Kirsten Valley |
| K231466 |
05/19/2023 |
RxSight Insertion Device |
RxSight, Inc. |
Maureen O'Connell |
| K231439 |
05/17/2023 |
Powder Free White, Black, and Purple Nitrile Examination Glove |
S&S Glove Corporation |
Poppy Farrah Rossa |
| DEN230041 |
05/31/2023 |
Sleep Apnea Feature |
Samsung Electronics Co., Ltd |
Hon Pak |
| K231521 |
05/26/2023 |
Broncho Videoscope System |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K231408 |
05/15/2023 |
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile |
Shandong Intco Medical Products Co, Ltd. |
Max Li |
| K231482 |
05/23/2023 |
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 |
| K231572 |
05/31/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K231367 |
05/11/2023 |
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) |
Shenzhen Finicare Co., Ltd. |
Chao Li |
| K231497 |
05/24/2023 |
Choledochoscope System |
Shenzhen HugeMed Medical Technical Development Co., Ltd |
Cathy Shi |
| K231310 |
05/05/2023 |
Electronic Blood Pressure Monitor |
Shenzhen Jumper Medical Equipment Co., Ltd. |
Danyin Li |
| K231321 |
05/08/2023 |
Nooance Led And Laser Helmet |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
Alain Dijkstra |
| K231423 |
05/17/2023 |
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) |
Shenzhen Roundwhale Technology Co. Ltd. |
Zeng Chunming |
| K231440 |
05/18/2023 |
Combo Electrotherapy Device |
Shenzhen Roundwhale Technology Co., Ltd. |
Zeng Chunming |
| K231577 |
05/31/2023 |
MOBILETT Impact |
Siemens Medical Solutions |
Camila Rodriguez Valentin |
| K231587 |
05/31/2023 |
MAGNETOM Cima.X |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K231560 |
05/30/2023 |
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K231351 |
05/09/2023 |
Chondral Quant |
Siemens Medical Soultions USA, Inc. |
Milind Dhamankar |
| K231286 |
05/04/2023 |
Chemfort« Catheter Adaptor |
Simplivia Healthcare LTD. |
Shay Shaham |
| K231476 |
05/22/2023 |
TRUENESSÖ AIR Blood Glucose Monitoring System; TRUENESSÖ Blood Glucose Monitoring System |
Sinocare Inc. |
Qian Zhou |
| K231447 |
05/18/2023 |
Double Internal Joint Stabilizer- Elbow |
Skeletal Dynamics Inc |
Alexandra Rodriguez Rojas |
| K231276 |
05/02/2023 |
SmartCardia 7L Platform |
SmartCardia SA |
Srinivasan Murali |
| K231558 |
05/30/2023 |
SMB Luer lock disposable syringe |
SMB Corporation of India |
Anupam Rai |
| K231394 |
05/15/2023 |
Intense Pulsed Light System |
Smedtrum Medical Technology Co., Ltd. |
Crimson Wu |
| K231376 |
05/12/2023 |
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) |
Smith & Nephew Inc. |
Pragnya Bakka |
| K231448 |
05/18/2023 |
TANDEM Hip System |
Smith & Nephew, Inc. |
Nikita Deshpande |
| K231537 |
05/30/2023 |
SofWave System |
Sofwave Medical Ltd. |
Ruthie Amir, MD |
| K231550 |
05/30/2023 |
Sontro« OTC Hearing Aids (AI) |
Soundwave Hearing, LLC |
Anthony Florek |
| K231457 |
05/19/2023 |
SPARK Scan |
SPARK Neuro Inc. |
Marinela Gombosev |
| K231551 |
05/30/2023 |
Stethophone |
Sparrow Acoustics Inc. |
Nadia Ivanova |
| K231523 |
05/26/2023 |
EsCom250 |
Spident Co., Ltd. |
Eunok Choi |
| K231252 |
05/01/2023 |
VentanaÖ L Spinal System |
Spinal Elements, Inc. |
Julie Lamothe |
| K231275 |
05/02/2023 |
ExceedÖ Biplanar Expandable Interbody System |
Spine Wave, Inc. |
Ronald K. Smith |
| K231488 |
05/23/2023 |
CelerityÖ HP Chemical Indicator; CelerityÖ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape |
STERIS |
Anthony Piotrkowski |
| K231490 |
05/23/2023 |
Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator |
STERIS Corporation |
Gregory Land |
| K231501 |
05/24/2023 |
PRO-LITE Sterilization Tray |
STERIS Corporation |
Jennifer Nalepka |
| K231500 |
05/24/2023 |
Vis-U-All Low Temperature Sterilization Pouches |
Steris Corporation |
Jennifer Nalepka |
| K231325 |
05/08/2023 |
Corplex P / Theracor P / Allacor P |
StimLabs, LLC |
Melissa O'Connor |
| K231262 |
05/01/2023 |
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System |
Stryker GmbH |
Danese Joiner-Fox |
| K231257 |
05/01/2023 |
Pangea Utility Plating System, Pangea Platform |
Stryker GmbH |
Danese Joiner-Fox |
| K231489 |
05/23/2023 |
Sturdy Autoclave Super Microm |
Sturdy Industrial Co., Ltd |
Wolfgang Huang |
| K231260 |
05/01/2023 |
HTx Disposable Hysteroscope System |
Suzhou AcuVu Medical Technology Co., Ltd. |
Sam Mostafavi |
| K231554 |
05/30/2023 |
UniPearls« Embolic Microspheres |
Suzhou Haowei Medical Technology Co., Ltd. |
Jinyan Shi |
| K231472 |
05/22/2023 |
Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) |
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. |
Ryan Chen |
| K231400 |
05/15/2023 |
Bladeless Trocar û Artemis Lap Cannula |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K231336 |
05/08/2023 |
T2 Biothreat Panel |
T2 Biosystems, Inc. |
Rachel Gilbert |
| K231559 |
05/30/2023 |
Multi-Unit DAS System |
Talladium Espa±a, SL |
Xavier Soca Filella |
| K231520 |
05/25/2023 |
tmCMF Solution |
TechMah CMF |
Mohamed Mahfouz |
| K231383 |
05/12/2023 |
Terragene« Bionova« Self-Contained Biological Indicator (BT95), Terragene« Bionova« Self-Contained Biological Indicator (BT96), Terragene« Chemdye« Chemical Process Indicator (CD42), Terragene« Cintape« Chemical Process Indicator Tape (CT40) |
Terragene SA |
Hernando Carrizo |
| K231434 |
05/17/2023 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K231290 |
05/04/2023 |
Optilite« Freelite« Kappa Free Kit, Optilite« Freelite« Lambda Free Kit |
The Binding Site Ltd. |
Jolanta Wolff |
| K231433 |
05/17/2023 |
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K231362 |
05/11/2023 |
OCS Heart Leukocyte Depleting Filter |
TransMedics, Inc. |
Miriam Provost |
| K231339 |
05/08/2023 |
Tyber Medical Pin and Wire System (various) |
Tyber Medical, LLC |
Nicole Merlini |
| K231317 |
05/08/2023 |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K231315 |
05/05/2023 |
Velox Power Chair |
Velox Manufacturing Inc |
Ryan Batke |
| K231388 |
05/12/2023 |
NextDent Base |
Vertex-Dental B.V. |
Connie Peterse-van der Koppel |
| K231343 |
05/09/2023 |
Redemption Duo Hindfoot Nail System |
Vilex LLC |
Brock Johnson |
| K231504 |
05/24/2023 |
TITANEXÖ MICROBEAM Screw System, TITANEXÖ ARTEMIS Screw System |
Vilex LLC |
Brock Johnson |
| K231493 |
05/23/2023 |
NITINEX Memory Compression Staple |
Vilex, LLC |
Brock Johnson |
| K231398 |
05/15/2023 |
VUNO Med-DeepBrain |
VUNO Inc. |
Jiwon Song |
| K231380 |
05/12/2023 |
AirLife DuoThermÖ Humidification System |
Vyaire Medical, Inc. |
Megan Walsh |
| K231288 |
05/04/2023 |
Vyvo |
Vyvo Technology Corp.(VT) |
Alfonso Cioffi |
| K231505 |
05/24/2023 |
GORE« ACUSEAL Vascular Graft |
W. L. Gore & Associates, Inc. |
Sarah Pastrnak |
| K231445 |
05/18/2023 |
LINK Embrace Shoulder System - Reverse Configuration |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K231289 |
05/04/2023 |
S-Patch Ex Wearable ECG Patch |
Wellysis Corp. |
DoGyun Im |
| K231478 |
05/22/2023 |
Digital Blood Pressure Monitor (Model: YB-800) |
Wenzhou Yosun Medical Technology Co.,Ltd |
Xiao Yuan Lan |
| K231542 |
05/30/2023 |
Digital Blood Pressure Monitor WBP Series |
Weony (Shenzhen) Technology Co., Ltd. |
Autumn Liu |
| K231564 |
05/31/2023 |
Skin and Wound Cleanser |
Winner Medical Co., Ltd. |
Mingni Liu |
| K231273 |
05/02/2023 |
ArcherQA (V1.0) |
Wisdom Technologies., Inc. |
Xie Xu |
| K231461 |
05/19/2023 |
Smart Correction System (HA Half Pins) |
WishBone Medical, Inc. |
Kellie Myers |
| K231548 |
05/30/2023 |
Medical Diode Laser, Model S1Pro |
Wuhan Pioon Technology Co., Ltd. |
Feng Zhang |
| K231425 |
05/17/2023 |
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) |
Wuxi Jiajian Medical Instrument Co., Ltd |
Wu Zhifang |
| K231420 |
05/16/2023 |
Aura 10 PET/CT |
XEOS Medical |
Bjorn Delbeecke |
| K231510 |
05/25/2023 |
Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) |
Xiantao Zhibo Non-Woven Products Co., Ltd. |
Fen Peng |
| K231471 |
05/22/2023 |
Air/Water Bottle Tubing, CO2 Source Tubing |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K231508 |
05/25/2023 |
Power Wheelchair, W5521 |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
Grace Li |
| K231428 |
05/17/2023 |
Mobility Scooter (Models: W3431D) |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
Grace Li |
| K231341 |
05/09/2023 |
Organic cotton tampon, Viscose tampon |
Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. |
Roy Du |
| K231320 |
05/08/2023 |
Zhenjiang Assure Mechanical Wheelchair,model:K1 |
Zhenjiang Assure Medical Equipment Co.,Ltd. |
Eric Shi |
