| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K223780 |
07/06/2023 |
Lumos 3DX |
3Dio |
Douglas Hansen |
| K221664 |
07/03/2023 |
CLEARinse CTS Specimen Collection and Transport System |
Aardvark Medical, Inc. |
Steven Bacich |
| K223317 |
07/21/2023 |
Alkaline Phosphatase2 |
Abbott Ireland Diagnostics Division |
Julian Braz |
| K220282 |
07/14/2023 |
i-STAT PTplus Cartridge with the i-STAT 1 System |
Abbott Laboratories |
Melissa Tristani |
| K223710 |
07/28/2023 |
i-STAT CG8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Jacquelyn Gesumaria |
| K231279 |
07/05/2023 |
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm |
Ablative Solutions, Inc. |
Kristine Canavan |
| K231862 |
07/21/2023 |
TruDi« Navigation System V3 (FG-2000-00) |
Acclarent, Inc. |
Kamrie Sarnosky |
| K230532 |
07/12/2023 |
RADx Intraoral Appliance for Snoring and Sleep Apnea |
Achaemenid LLC |
Rachel Miller |
| K231091 |
07/10/2023 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical Inc |
Karla Schaffner |
| K231769 |
07/13/2023 |
activL« Next Generation Instrumentation |
Aesculap Implants Systems LLC |
Hamza Ahmed |
| K223382 |
07/07/2023 |
AeviceMD |
Aevice Health Pte. Ltd. |
Adrian Ang |
| K231951 |
07/28/2023 |
SI-Cure Sacroiliac Joint Fusion System |
Alevio, LLC |
Trey Robbins |
| K231438 |
07/13/2023 |
Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System |
Alphatec Spine, Inc. |
Unnati Bhuptani |
| K231261 |
07/27/2023 |
Altaviz Needle Kit II |
Altaviz, LLC |
James Lescoulie |
| K232088 |
07/31/2023 |
Altris IMS |
Altris, Inc. |
Andrew Kuropyatnyk |
| K232011 |
07/07/2023 |
Cleo |
American Orthodontics |
Laura Richmond |
| K231945 |
07/20/2023 |
VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits |
AngioDynamics, Inc. |
Laura Dwyer |
| K230680 |
07/11/2023 |
Anthogyr Surgical Cassettes |
Anthogyr |
Aude Goulet |
| K231173 |
07/21/2023 |
Irregular Rhythm Notification Feature (IRNF) |
Apple Inc. |
Bonnie Wu |
| K223322 |
07/24/2023 |
Argus Cognitive ReVISION Software |
Argus Cognitive, Inc. |
Attila Meretei |
| K230257 |
07/17/2023 |
Arthrex Intramedullary Nails |
Arthrex, Inc. |
Stacy Valdez |
| K230725 |
07/01/2023 |
NB Implant System |
Arum Dentistry Co., Ltd. |
Boyeon Lim |
| K230377 |
07/20/2023 |
CROSSLEAD Penetration Peripheral Guide Wire |
ASAHI INTECC Co., Ltd. |
Katsuhiko Fujimura |
| K230823 |
07/12/2023 |
AusculThing ACC |
AusculThing Oy |
Jani Virtanen |
| K231456 |
07/17/2023 |
Avitus« DragonWing Large Volume Autograft Delivery System |
Avitus Orthopaedics, Inc. |
Maxim Budyansky |
| K222745 |
07/03/2023 |
Axial3D Insight |
Axial Medical Printing Limited |
Jenna McGarry |
| K222794 |
07/28/2023 |
FlowStar Touch Digital Mixer Flowmeter |
Baldus Sedation GmbH & Co. KG |
Lisa Baldus |
| K230956 |
07/31/2023 |
BD Respiratory Viral Panel for BD MAXÖ System; BD Respiratory Viral Panel-SCV2 for BD MAXÖ System |
BD Integrated Diagnostic Solutions/ |
Kathy Barnecut |
| K220977 |
07/20/2023 |
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer |
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. |
Tracy Jin |
| K213953 |
07/17/2023 |
BD Vacutainer« Trace Element K2EDTA Tubes, BD Vacutainer« Trace Element Serum Tubes |
Becton Dickinson and Company |
Angela Mariani |
| K231161 |
07/21/2023 |
0.9% Sodium Chloride Injection, USP BD PosiFlushÖ SF Saline Flush Syringe |
Becton, Dickinson and Company |
Samhitha Mohan |
| K231318 |
07/07/2023 |
Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) |
Beijing ADSS Development Co., Ltd. |
Song Ying |
| DEN220058 |
07/07/2023 |
BT-001 |
Better Therapeutics |
Heather Hill |
| K230864 |
07/05/2023 |
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 ╡g/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 ╡g/mL), VITEK 2 AST-GP Daptomycin |
BioMerieux, Inc |
Jared Bronson |
| K230540 |
07/25/2023 |
Patient Specific Planning SolutionÖ 3D Bone Models |
Biomet Manufacturing Corp. |
Katherine Choi |
| K223631 |
07/12/2023 |
Comprehensive Segmental Revision System(SRS) |
Biomet Orthopedics |
Alexandria Irwin |
| K231312 |
07/10/2023 |
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 |
07/10/2023 |
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 |
| K231528 |
07/11/2023 |
Bonalive Orthopedics granules |
Bonalive Biomaterials, Ltd. |
Kristoffer Sibelius |
| K231292 |
07/19/2023 |
TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System |
Bonebridge AG |
Michelle Gumpelmayer |
| K230269 |
07/14/2023 |
UltraflexÖ Tracheobronchial Stent System |
Boston Scientific Corporation |
Catherine Sanford |
| K223106 |
07/14/2023 |
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) |
Brainlab AG |
Marc Bergenthal |
| K223288 |
07/21/2023 |
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI |
Brainlab AG |
Esther Moreno Garcia |
| K231195 |
07/27/2023 |
Brainomix 360 Triage ICH |
Brainomix Limited |
Szrnka Zsolt |
| K230942 |
07/11/2023 |
SPIRA« Posterior Lumbar Spacers |
Camber Spine Technologies |
Brooks McAdam |
| K223261 |
07/13/2023 |
Open Rib |
Canon Medical Informatics, Inc. |
Vincent Swenson |
| K231280 |
07/03/2023 |
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 |
| K222874 |
07/26/2023 |
CarboClear Cervical Cage System, CarboClear Cervical VBR System |
CarboFix Orthpedics Ltd. |
Yael Rubin |
| K230569 |
07/03/2023 |
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) |
Cardinal Health |
Caroline Miceli |
| K230838 |
07/27/2023 |
Cardinal HealthÖ SmartGownÖ EDGE Breathable Surgical Gown with ASSISTÖ Instrument Pockets |
Cardinal Health 200, LLC |
Emily Hunter |
| K221319 |
07/21/2023 |
BD AlarisÖ Pump Epidural Infusion Set |
CareFusion |
Paulina Davis |
| K221327 |
07/21/2023 |
BD AlarisÖ Pump Infusion Sets |
CareFusion |
Roya Borazjani |
| K211218 |
07/21/2023 |
BD Alaris System with Guardrails Suite MX v12.1.2 |
CareFusion 303 Inc. |
Laurie Cartwright |
| K230858 |
07/31/2023 |
QUATERA 700 |
Carl Zeiss Meditec AG |
Hans-Joachim Miesner |
| K222220 |
07/06/2023 |
SpinMedix Absorbable Fibrous Membrane |
CelestRay Biotech Company, LLC |
Charles C Han |
| K223097 |
07/31/2023 |
RenaNav Ureteroscope System |
CenterPoint Systems LLC |
Marybeth Gamber |
| K223752 |
07/24/2023 |
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl |
Central Medicare Sdn. Bhd. |
Chua Kah Ying |
| K230875 |
07/20/2023 |
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims |
Central Medicare Sdn. Bhd. |
Chua Kah Ying |
| K230016 |
07/14/2023 |
Cercare Medical Neurosuite |
Cercare Medical A/S |
Peter Loekke |
| K223316 |
07/21/2023 |
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System |
Conformis Inc. |
Mary Kruitwagen |
| K230846 |
07/17/2023 |
iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System |
Conformis, Inc. |
Nancy Giezen |
| K231172 |
07/26/2023 |
ApolloKnee |
Corin USA Limited |
Aaron Brunt |
| K231861 |
07/21/2023 |
EndoflipTM 300 System |
Covidien LLC |
Viviana Gonzalez |
| K230510 |
07/06/2023 |
MyEllevate |
Cynosure, LLC |
Cynthia Aguirre |
| K231437 |
07/19/2023 |
LF900 |
Daesung Maref Co., Ltd |
Su Hyeon So |
| K213536 |
07/25/2023 |
DEKA ACE Pump System |
DEKA Research and Development |
Paul Smolenski |
| K230307 |
07/11/2023 |
Dentis i-Clean System |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K231516 |
07/21/2023 |
INHANCEÖ Shoulder System, Sterile Single Use Instrumentation |
Depuy Ireland UC |
Yayoi Fujimaki |
| K231922 |
07/26/2023 |
DEPUY SYNTHES MAXFRAME AUTOSTRUT System |
Depuy Synthes |
Mitchel Bartko |
| K221961 |
07/13/2023 |
HydroMARK Plus Breast Biopsy Site Marker |
Devicor Medical Products, Inc. |
Katy Austin |
| K231552 |
07/28/2023 |
Dia-Cem |
Diadent Group International |
Kab Sun Lee |
| K230931 |
07/23/2023 |
Atlan |
DrΣgerwerk AG Co. KGaA |
Marianne Selent |
| K230395 |
07/17/2023 |
Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) |
DURIO PPE SDN BHD |
Xavier Kong |
| K231886 |
07/27/2023 |
SURGIVISIO Device |
Ecential Robotics |
Elodie Bouillet |
| K222902 |
07/28/2023 |
Electrocardiograph: SE-1200 Pro and SE-1201 Pro |
Edan Instruments, Inc. |
Milin Wu |
| K231035 |
07/12/2023 |
FusedCO Algorithm |
Edwards Lifesciences LLC |
Omar Becerra |
| K231038 |
07/26/2023 |
Global Hypoperfusion Index (GHI) Algorithm |
Edwards Lifesciences, LLC |
Michelle Ducca |
| K231900 |
07/25/2023 |
A-TAP (previously called Arthrotap) |
Elcam Medical ACAL |
Yaniv Menachem |
| K223791 |
07/14/2023 |
TalWire |
Embrace Medical Ltd. |
Anat Kaufman |
| K231474 |
07/21/2023 |
Erchonia Violet ZERONA« Z6 OTC |
Erchonia Corporation |
Travis Sammons |
| K230730 |
07/25/2023 |
Apyx |
Escala Medical |
Edit Goldberg |
| K231073 |
07/28/2023 |
SkinStylus SteriLock« MicroSystem, Model Number MP1209SL |
Esthetic Medical Inc. |
Kristin Groop |
| K223578 |
07/07/2023 |
T3 Platform software |
Etiometry, Inc. |
Timothy Hanson |
| K231410 |
07/19/2023 |
RenaPure Endotoxin Retentive Filter |
Evoqua Water Technologies LLC |
Robert Dudek |
| K231757 |
07/14/2023 |
Ez3D-i /E3 |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K223252 |
07/17/2023 |
TRULIANT« E-PX Tibial Inserts; TRULIANT« E-PX Patellas |
Exactech, Inc |
Elizabeth Howell |
| K230898 |
07/28/2023 |
FLUOBEAM« LX Red |
Fluoptics Sas |
Marion Boudet |
| K230945 |
07/18/2023 |
Forma Medical Headless Compression Screw |
Forma Medical, Inc. |
James A. Gault |
| K223426 |
07/13/2023 |
ECHELON Synergy MRI system |
FUJIFILM Healthcare Corporation |
Randy Vader |
| K230487 |
07/03/2023 |
Dental Lithium Disilicate Glass-Ceramic |
Fuzhou Rick Brown Biomaterials Co., Ltd. |
Zhong Huang |
| K230932 |
07/07/2023 |
ANDORATE« Valve Kit |
GA Health Company Limited |
Cindy Ye |
| DEN220047 |
07/19/2023 |
Galen ES Cooperative Surgical Assistant Platform, Galen ES |
Galen Robotics |
Robert Lawery |
| K223424 |
07/13/2023 |
Spine Auto Views |
GE Medical Systems SCS |
Yonghui Han |
| K230787 |
07/20/2023 |
Oscar 15 & Oscar 15i |
Genoray Co., Ltd. |
Jiyeon Lee |
| K231480 |
07/28/2023 |
Bright MTA Sealer Plus |
Genoss Co., Ltd. |
Boram Choi |
| K231714 |
07/12/2023 |
Graftys Quickset |
Graftys |
Cedric Bonneau |
| K231808 |
07/20/2023 |
QUASAR Standalone ACIF System |
GS Medical Co. Ltd. |
Seon Yeon Kim |
| K230407 |
07/17/2023 |
FloNavi Open Field Fluorescence Imaging System |
Guangdong OptoMedic Technologies, Inc. |
Alice Lau |
| K231003 |
07/06/2023 |
Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) |
Guangdong OptoMedic Technologies, Inc. |
Weijuan Guo |
| K230001 |
07/05/2023 |
Electric Scooter (Model: M2020) |
Guangdong Prestige Technology Co., Ltd. |
Zhang Zhao |
| K222587 |
07/28/2023 |
PatCom Distal Chip Endoscope |
H&A Mui Enterprises Inc. |
Tammy Mui |
| K231698 |
07/31/2023 |
AllTest Fentanyl Rapid Test (Urine) |
Hangzhou AllTest Biotech Co., Ltd. |
Rosa Wu |
| K231568 |
07/06/2023 |
HardyDisk AST Sulbactam/Durlobactam 10/10╡g (SUD20) |
Hardy Diagnostics |
Anna Klavins |
| K222735 |
07/28/2023 |
HJY VisualNext Endoscopic Vision System |
HJY Smart Medical Device Co., Ltd. |
John Jiannyuh Chen |
| K221767 |
07/31/2023 |
Surgical Sutures with or without Needle |
Huaian Seamen Medical Technology Co., LTD |
Xinjie Zhang |
| K231711 |
07/11/2023 |
microINR System |
iLine Microsystems S.L. |
Miren Itsaso Hormaeche |
| K223728 |
07/13/2023 |
Micro Rx |
IMDS Operations B.V. |
Edwin Schulting |
| K230913 |
07/25/2023 |
ANDI |
Imeka Solutions, Inc. |
Valerie Lacroix |
| K223781 |
07/28/2023 |
QuantisalÖ II Oral Fluid Collection Device |
Immunalysis Corporation |
Shubhajit Mitra |
| K231236 |
07/27/2023 |
IBS-B MIS Beveled Screw System |
In2Bones USA, LLC |
Christine Scifert |
| K231782 |
07/14/2023 |
FlowSaver Blood Return System (80-101) |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K231848 |
07/21/2023 |
Triever20 Curve (21-201) |
Inari Medical, Inc. |
Anthony Lam |
| K231790 |
07/20/2023 |
The InMode System with the Morpheus8 Applicators |
InMode Ltd. |
Suhair Francis |
| K221137 |
07/11/2023 |
Play and Joy Water-Based Lubricant |
InnoveMed Bio-tech Co., Ltd. |
Linda Li |
| K220646 |
07/10/2023 |
Play&Joy InvisiLube Lubricant Capsule |
InnoveMed Bio-tech Co., Ltd. |
David Chien |
| K223484 |
07/20/2023 |
IGAR System (1001.A) |
Insight Medbotics Inc. |
Paul Chipperton |
| K230427 |
07/11/2023 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra Lifesciences Corporation |
Alexandra Wells |
| K231358 |
07/05/2023 |
Universal Seal (5-12 mm) |
Intuitive Surgical, Inc. |
Emily Hovick |
| K230074 |
07/27/2023 |
Rapid Aneurysm Triage and Notification |
iSchemaView Inc. |
James Rosa |
| K231555 |
07/27/2023 |
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) |
iSMART Developments Ltd |
Susan D'Arcy |
| K230025 |
07/03/2023 |
IVYLASER Handhold Hair Removal Machine |
Ivylaser (Beijing) Technology Co., Ltd. |
Yuan Xiujuan |
| K230630 |
07/31/2023 |
ZENEX Implant System_Narrow |
Izenimplant Co., Ltd. |
Kwon Mi-Kyung |
| K231441 |
07/17/2023 |
ARIX Ankle System |
Jeil Medical Corporation |
Dajung Lee |
| K230804 |
07/07/2023 |
Complement Kit Cases |
JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A. |
Barbara Uzae |
| K222026 |
07/14/2023 |
Neodent Implant System - Zirconia Implant System |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Barbara Uzae |
| K231460 |
07/16/2023 |
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 |
| K230333 |
07/24/2023 |
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) |
Kettenbach GmbH & Co. KG |
Katja Simon |
| K231021 |
07/21/2023 |
KIMTECHÖ PolarisÖ 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 |
| K231839 |
07/19/2023 |
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System |
L & K Biomed Co., Ltd. |
Katherine Kim |
| K231840 |
07/20/2023 |
CastleLoc-S Posterior Cervical Fixation System |
L & K Biomed Co., Ltd. |
Katherine Kim |
| K231841 |
07/14/2023 |
PathLoc SI Joint Fusion System |
L & K Biomed Co., Ltd. |
Katherine Kim |
| K222925 |
07/18/2023 |
Hypodermic Syringes & Needle |
Lifelong Meditech Private Limited |
Mr. Hamendra Nath Srivastava |
| K230720 |
07/03/2023 |
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 |
Light Tree Ventures Europe B.V. |
Kim Laurens |
| K231925 |
07/11/2023 |
MINIMA S System |
LimaCorporate S.p.A. |
Kenneth Newman |
| K222862 |
07/30/2023 |
SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC |
Lotuxs Medtech (Suzhou) Co., Ltd. |
Na Wu |
| K231387 |
07/10/2023 |
Endofill |
Lumendo AG |
Mark Bispinghoff |
| K221058 |
07/05/2023 |
LungTrainer (MD2 & MD3) |
Lung Trainers, LLC |
Frank Acosta |
| K223499 |
07/21/2023 |
Three Way Stop Cock |
M/s Romsons International |
Kishore Narian Khanna |
| K223473 |
07/25/2023 |
ME-APDSÖ; MAGENTIQ-COLOÖ |
Magentiq Eye LTD |
Dror Zur |
| K223834 |
07/20/2023 |
AccuCheck |
Manteia Technologies Co., Ltd. |
Yingkai Lin |
| K223724 |
07/10/2023 |
MOZI TPS |
Manteia Technologies Co., Ltd. |
Chao Fang |
| K230173 |
07/06/2023 |
Servo-air Lite Ventilator System |
Maquet Critical Care AB |
David Ardanius |
| K231483 |
07/21/2023 |
MySpine Unilateral Guides |
Medacta International S.A. |
Stefano Baj |
| K223769 |
07/21/2023 |
NextARÖ Spine Platform |
Medacta International S.A. |
Stefano Baj |
| K223388 |
07/07/2023 |
Invia« Integrated Dressing |
Medela AG |
Judith Bernardo |
| K231668 |
07/07/2023 |
Spine CAMPÖ (1.1) |
Medical Metrics, Inc. |
Kirk Johnson |
| K223125 |
07/13/2023 |
XR90 (XR90-SYS) |
MediView XR, Inc. |
Adam Cargill |
| K231103 |
07/20/2023 |
ROSA ONE Brain Application |
Medtech S.A.S |
Paul Hardy |
| K230716 |
07/18/2023 |
Robotic Graft Delivery Instruments |
Medtronic Sofamor Danek Inc |
Diamond Wallace |
| K231754 |
07/13/2023 |
PraxijectÖ 0.9% NaCl |
MedXL Inc. |
Hina Saini |
| K223339 |
07/18/2023 |
Bone Chamber Implant |
MegaGen Implant Co., Ltd. |
Eun Mi Park |
| K230901 |
07/03/2023 |
Premier HpSA Flex (619096) |
Meridian Bioscience, Inc. |
Heather Planck |
| K223670 |
07/28/2023 |
MESI mTablet ECG Diagnostic System, MESI mTablet ECG |
MESI, Development of Medical Devices, Ltd; MESI, D.O.O. |
Jakob Susteric |
| K213100 |
07/18/2023 |
FMT Reusable Temperature Probes |
Metko Medikal ve Ttbbi Cihazlar D1s Ticaret Ltd. Sti |
Burcu Firat |
| K231641 |
07/05/2023 |
Rotium Bioresorbable Wick |
Nanofiber Solutions, LLC |
Jason Chakroff |
| K231241 |
07/12/2023 |
NanoHive Medical Lumbar Interbody System |
NanoHive Medical LLC |
Ian Helmar |
| K231392 |
07/14/2023 |
NaviNetics Reusable Stereotactic System (NN1000) |
NaviNetics Inc. |
Danielle Jondal |
| K230077 |
07/17/2023 |
LaserME |
Neauvia North America |
Joy Willard |
| K230801 |
07/28/2023 |
Pathfinder Endoscope Overtube with Balloon Device |
Neptune Medical, Inc. |
Alex Tilson |
| K222683 |
07/17/2023 |
Fibroid Mapping Reviewer Application (FMRA) |
Nesa Medtech Private Limited |
Sreekar Kothamachu |
| K231799 |
07/20/2023 |
INERTIA« CONNEXXÖ Modular Pedicle Screw System |
Nexxt Spine LLC |
Andy Elsbury |
| K223567 |
07/31/2023 |
CNS-2101 Central Monitor |
Nihon Kohden Corporation |
Sandra Gadeyne |
| K231589 |
07/28/2023 |
Blood Tubing Lines for Hemodialysis AV06C-E |
Nikkiso Co., Ltd. |
Satoko Hina |
| K231449 |
07/13/2023 |
Portable X-ray System Model Ray98(P) |
Ningbo Runyes Medical Instrument Co., Ltd. |
Weiqiong Fang |
| K223151 |
07/19/2023 |
Nu-beca Transcutaneous Electrical Nerve Stimulation |
Nu-Beca & Maxcellent Co. |
David Tsai |
| K210801 |
07/19/2023 |
AXINON« LDL-p Test System |
numares AG |
Stefanie Dukorn |
| K231735 |
07/11/2023 |
NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System |
NuVasive, Incorporated |
Hannah Tan |
| K222015 |
07/05/2023 |
Integral Titanium Cervical Interbody |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K213098 |
07/20/2023 |
Panther 5 |
Origin Medical Devices |
Brent Chamblee |
| K231618 |
07/28/2023 |
3 Layer Surgical Mask (134252531) |
Original Mattress Factory Inc. |
Nathan Elseser |
| K231386 |
07/11/2023 |
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste |
Orthocon, Inc. |
Aniq Darr |
| K231253 |
07/07/2023 |
Overture Orthopaedics Patellofemoral System |
Overture Resurfacing Inc. |
Riley Williams |
| K231249 |
07/28/2023 |
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 |
| K230087 |
07/17/2023 |
ôPOINTö Kinguide Agile Hybrid Navigation System |
Point Robotics Medtech Inc. |
Sandy Lin |
| K231844 |
07/07/2023 |
ProMISÖ Fixation System |
Premia Spine Ltd. |
Dorit Winitz |
| K231709 |
07/12/2023 |
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 |
Radmedix LLC |
Gabriel Issa |
| K230150 |
07/21/2023 |
OptimMRI |
RebrAIn, SAS |
Ram Bedi |
| K223747 |
07/06/2023 |
Whitsundays Mask System |
ResMed Pty Ltd (Registration Number: 3004604967) |
Shu-Ying Huang |
| K231313 |
07/28/2023 |
Therapy Mask 3100 NC/SP |
Respironics Inc. |
Shipra Gulati |
| K221107 |
07/18/2023 |
TRUST |
Rgorithm Korea |
Jun Ho Song |
| K220765 |
07/26/2023 |
HS Fiber Cerclage |
Riverpoint Medical, LLC |
Edwin Anderson |
| K230455 |
07/25/2023 |
Enamel Coating Resin |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| K223637 |
07/21/2023 |
Elecsys proBNP II, Elecsys proBNP II STAT |
Roche Diagnostics |
Jane Phillips |
| K223591 |
07/27/2023 |
cobas« SARS-CoV-2 & Influenza A/B for use on the cobas« Liat System |
Roche Molecular Systems, Inc. |
Aradhana Karthikeyan |
| DEN230012 |
07/14/2023 |
Ruthless Spine RJB |
Ruthless, LLC dba Ruthless Spine |
Renita Howard |
| K221056 |
07/06/2023 |
ARGUS PB-3000 |
SCHILLER AG |
Iru Rothfuchs |
| K231787 |
07/26/2023 |
ecoFIX« |
Science & Bio materials (S.B.M.) SAS |
Anne Cospin |
| K223290 |
07/14/2023 |
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) |
SentiAR, Inc. |
Alexander Schreiner |
| K222707 |
07/07/2023 |
IH Implant System |
Sewon Medix Inc. |
Jinsoo Lee |
| K223189 |
07/21/2023 |
FirefighterÖ NC Pro PTCA Balloon Catheter |
Shanghai MicroPort Medical (Group) Co., Ltd. |
Xia Tian |
| K231931 |
07/28/2023 |
Adena-Zina Spinal System |
Shanghai Sanyou Medical Co, LTD |
David Fan |
| K230039 |
07/20/2023 |
uOmnispace |
Shanghai United Imaging Healthcare Co., Ltd |
Gao Xin |
| K231572 |
07/26/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K223037 |
07/21/2023 |
Infrared Thermometer, Model: IR8807 |
Shen Zhen Rong Feng Technology Co., Ltd |
Hong Xiao Lan |
| K230968 |
07/06/2023 |
VYBE RF Electrosurgical System |
ShenB Co Ltd |
Sunny Kang |
| K222994 |
07/26/2023 |
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B |
Shenzhen AOJ Medical Technology Co., Ltd. |
Jack Wang |
| K211143 |
07/17/2023 |
Pulse Oximeter |
Shenzhen brav electronic technologies co., Ltd |
Kai Wang |
| K231321 |
07/31/2023 |
Nooance Led And Laser Helmet |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
Alain Dijkstra |
| K223886 |
07/14/2023 |
Wearable Breast Pump (Model S18) |
Shenzhen TPH Technology Co., Ltd. |
Peter Chen |
| K222438 |
07/25/2023 |
A-LYTE« Integrated Multisensor (IMT Na K Cl) |
Siemens Healthcare Diagnostics Inc. |
Joy Anoop |
| K222116 |
07/13/2023 |
Atellica« CI Analyzer, Atellica« IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica« CH Albumin BCP (AlbP) |
Siemens Healthcare Diagnostics Inc. |
Joy Anoop |
| K221605 |
07/25/2023 |
Emit« II Plus Buprenorphine Assay |
Siemens Healthcare Diagnostics, Inc. |
Julie Warren |
| K231157 |
07/19/2023 |
syngo.CT Lung CAD (Version VD30) |
Siemens Healthcare GmbH |
Abhineet Johri |
| K231577 |
07/25/2023 |
MOBILETT Impact |
Siemens Medical Solutions |
Camila Rodriguez Valentin |
| K231833 |
07/13/2023 |
Biograph Vision.X and Biograph Vision.X Edge |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K231351 |
07/13/2023 |
Chondral Quant |
Siemens Medical Soultions USA, Inc. |
Milind Dhamankar |
| K223806 |
07/06/2023 |
VERTICALE« Triangular Fixation System |
Silony Medical GmbH |
Ralf Klabunde |
| K231064 |
07/13/2023 |
ReddyPort Elbow |
SMD Manufacturing LLC |
Jared Spendlove |
| K231448 |
07/19/2023 |
TANDEM Hip System |
Smith & Nephew, Inc. |
Nikita Deshpande |
| K230365 |
07/25/2023 |
Sonio Detect |
Sonio |
Florian Akpakpa |
| K231523 |
07/24/2023 |
EsCom250 |
Spident Co., Ltd. |
Eunok Choi |
| K221307 |
07/10/2023 |
Edge Upper Cervical System |
Spinal Simplicity LLC |
Adam Rogers |
| K231275 |
07/25/2023 |
ExceedÖ Biplanar Expandable Interbody System |
Spine Wave, Inc. |
Ronald K. Smith |
| K223301 |
07/20/2023 |
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System |
SpineCraft, LLC |
Ami Akallal-Asaad |
| K230445 |
07/14/2023 |
OnX Tough |
SprintRay Inc. |
Sara Moghtadernejad |
| K230560 |
07/21/2023 |
enspire 300 Series Automated Endoscope Reprocessor System |
STERIS Corporation |
Gregory Land |
| K230558 |
07/17/2023 |
Revital-Ox PAA High Level Disinfectant Chemical Indicator |
STERIS Corporation |
Gregory Land |
| K231878 |
07/25/2023 |
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 |
| K231223 |
07/27/2023 |
MDx-Chex for BC-GN |
Streck |
Cody A. Janssen |
| K231221 |
07/27/2023 |
MDx-Chex for BC-GP |
Streck |
Megan Hiveley |
| K231621 |
07/25/2023 |
Reprocessed ViewFlex Xtra ICE Catheter (D087031) |
Stryker Sustainability Solutions |
Mia Brown |
| K231472 |
07/19/2023 |
Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) |
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. |
Ryan Chen |
| K230037 |
07/19/2023 |
BACK 3 |
SWIMS America Corp |
Matthieu Commeau |
| K223213 |
07/10/2023 |
Tandem Mobi Insulin Pump with Interoperable Technology |
Tandem Diabetes Care, Inc. |
Ashley Schneider |
| K220980 |
07/05/2023 |
Tissue Approximation System (TAS) |
TAS Medical, Inc. |
Michael Tozzi |
| K231924 |
07/25/2023 |
EZ-IO Intraosseous Vascular Access System |
Teleflex Medical |
Rachel Rehl |
| K212077 |
07/27/2023 |
Teleflex Rusch SoftSimplastic Foley Catheters |
Teleflex Medical, Inc. |
Kelley Breheim |
| K231044 |
07/27/2023 |
R2P Navicross |
Terumo Medical Corporation |
Sandeep Chiplonkar |
| K231653 |
07/03/2023 |
BASHIRÖ .035 Endovascular Catheter, BASHIRÖ S-B .035 Endovascular Catheter |
Thrombolex, Inc. |
Amy Katsikas |
| K222666 |
07/10/2023 |
X-View 3D Pan/X-View 2D Pan |
Trident s.r.l |
Giorgio Rizzo |
| K231339 |
07/06/2023 |
Tyber Medical Pin and Wire System (various) |
Tyber Medical, LLC |
Nicole Merlini |
| K223347 |
07/24/2023 |
UltraSight AI Guidance |
UltraSight Inc. |
Davidi Vortman |
| K231740 |
07/04/2023 |
MemorialTM Gloves |
US Glove Supply |
Jacomo Hakim |
| K230576 |
07/25/2023 |
IDENTIFY |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K231796 |
07/19/2023 |
Grreen X 12 (Model: PHT-75CHS) |
Vatech Co., Ltd |
Daniel Kim |
| K230462 |
07/17/2023 |
OPTIX H2 Patient Specific Instrument System |
Vilex, LLC |
Brock Johnson |
| K231041 |
07/14/2023 |
JiveX (Model Number / Release: 5.4) |
VISUS Health IT GmbH |
Axel Schreiber |
| K230877 |
07/13/2023 |
Admira Fusion 5 |
VOCO GmbH |
Katrin Fr÷hlich |
| K231591 |
07/31/2023 |
V-Print c&b temp |
VOCO GmbH |
Sarah Schaudel |
| K223683 |
07/10/2023 |
EnteraLoc Flow |
Vonco Products |
Christie Marr |
| K223173 |
07/14/2023 |
Proxeo ULTRA (PB-510, PB-520 and PB-530) |
W&H Dentalwerk Buermoss GmbH |
Weidler Gerhard |
| K230813 |
07/28/2023 |
BlueStar and BlueStar Rx |
Welldoc, Inc. |
David Boser |
| K230611 |
07/13/2023 |
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) |
Xstrahl Ltd |
Vineet Gupta |
| K223448 |
07/07/2023 |
Bladder Scanner Model: BVT02 |
Xuzhou Kaixin Electronic Instrument Co., Ltd. |
Chunmei Xu |
| K230004 |
07/31/2023 |
Disposable Hemoclip |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K230080 |
07/07/2023 |
Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood |
Yangzhou Medline Industry Co., Ltd. |
Hu Tingting |
| K223808 |
07/12/2023 |
Zavation Navigation Instrument System |
Zavation Medical Products, LLC |
Katie Motley |
| K231912 |
07/27/2023 |
Therm-X |
Zenith Technical Innovations |
Greg Binversie |
| K221673 |
07/14/2023 |
Bonafix TiBase |
Zentek Medical LLC |
Michael Vinnik |
| K230863 |
07/13/2023 |
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit |
ZEUS Scientific |
Mark Kopnitsky |
| K231428 |
07/14/2023 |
Mobility Scooter (Models: W3431D) |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
Grace Li |
| K222920 |
07/20/2023 |
Oxygen concentrator |
Zhengzhou Olive Electronic Technology Co., Ltd. |
Yunping Qu |
| K231613 |
07/31/2023 |
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. |
Zhuzhou Goldenhot Medical Technology Co., Ltd. |
Liu Xianwu |
| K231701 |
07/10/2023 |
Ziehm Vision RFD 3D |
Ziehm Imaging GmbH |
Stefan Fiedler |
