| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K231585 |
06/30/2023 |
Vantage PSI System |
3D Systems, Inc. |
Ashley Dawson |
| K230937 |
06/05/2023 |
Alinity i Total ▀-hCG Reagent Kit, GLP systems Track |
Abbott Laboratories |
Melissa Vaughan |
| K231311 |
06/02/2023 |
CPS DirectÖ Universal slittable outer guide catheter (DS2C029) |
Abbott Medical |
Mary Adams |
| K231588 |
06/30/2023 |
ViewFlexÖ Eco Reprocessed ICE Catheter |
Abbott Medical |
Quynh Phuong Le |
| K221294 |
06/30/2023 |
preCARDIA Occlusion System |
Abiomed Inc. |
Ken Ryder |
| K230008 |
06/08/2023 |
Ablamap« System |
Ablacon, Inc. |
Frank Rodrigues |
| K230910 |
06/16/2023 |
NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens |
Acculens, Inc. |
Troy Miller |
| K231293 |
06/01/2023 |
DrakonÖ and Sequre« Microcatheters |
Accurate Medical Therapeutics |
Osnat Harbater |
| K222658 |
06/21/2023 |
Accurate 24 Non-invasive blood pressure monitor |
Accurate Meditech Inc. |
Wang Kuan Jen |
| K223159 |
06/23/2023 |
Radixact Treatment Delivery System |
Accuray Incorporated |
Karla Fields |
| K223013 |
06/23/2023 |
AccurECG Analysis System |
AccurKardia, Inc. |
Juan C. Jimenez |
| K222998 |
06/20/2023 |
F3 |
Acrew Imaging, Inc. |
Craig Hughes |
| K231532 |
06/23/2023 |
ActiGraph LEAP activity monitor (ActiGraph LEAP) |
ActiGraph, LLC |
Brian Bell |
| K230965 |
06/16/2023 |
Acuity 100Ö (hexafocon A) with TangibleÖ Hydra-PEG«, TYROÖ-97 (hofocon A) with TangibleÖ Hydra-PEG« Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
Chavez Jose |
| K230744 |
06/09/2023 |
Acumed Acutrak 3 Headless Compression Screw System |
Acumed LLC |
Phillip Saddik |
| K223669 |
06/12/2023 |
SecurePortIV Advanced Catheter Securement Adhesive |
Adhezion Biomedical, LLC. |
Richard Jones |
| K223596 |
06/29/2023 |
SQ.line KERRISON |
Aesculap Inc. |
Benjamin Oswald |
| K212409 |
06/30/2023 |
Ulspira TS Nitric Oxide Therapy System |
Airgas Therapeutics |
Steven Miller |
| K230892 |
06/09/2023 |
Fixone Biocomposite Anchor |
Aju Pharm Co., Ltd. |
Kwon Mingyeong |
| K222248 |
06/07/2023 |
Infrared Thermometer |
Alicn Medical Shenzhen, Inc |
Fang Meisong |
| K213046 |
06/27/2023 |
AceConnex Pre-Sutured Fascia |
AlloSource |
Trevor Wright |
| K223299 |
06/01/2023 |
Ambu« aScopeÖ 5 Broncho HD 5.0/2.2, Ambu« aScopeÖ 5 Broncho HD 5.6/2.8, Ambu« aViewÖ 2 Advance |
Ambu A/S |
Magnus Lynge |
| K231553 |
06/29/2023 |
OverStitch NXT Endoscopic Suturing System |
Apollo Endosurgery Inc. |
James Shene |
| K230586 |
06/09/2023 |
Renuvion« Micro Handpiece |
Apyx Medical Corporation |
Mark D Evans |
| K230904 |
06/22/2023 |
Arthrex Virtual Implant Positioning (VIP) System |
Arthrex Inc. |
Troy Brooks |
| K231330 |
06/01/2023 |
FiberTak« Suture Anchor |
Arthrex Inc. |
Erikka Edwardsen |
| K230914 |
06/26/2023 |
ARIS┐ COBLATION┐ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) |
Arthrocare Corporation |
Pragnya Bakka |
| K230866 |
06/29/2023 |
HotDog Warming Mattress + Return Electrode |
Augustine Temperature Management, LLC |
Garrett Augustine |
| K223871 |
06/22/2023 |
Miria Skin Treatment System |
Avava, Inc. |
Jay Bhawalkar, PhD |
| K230005 |
06/06/2023 |
Pantheris LV Atherectomy Catheter |
Avinger, Inc. |
Thomas Lawson |
| K230492 |
06/26/2023 |
Avitus« Precision Autograft Delivery System |
Avitus Orthopaedics, Inc. |
Maxim Budyansky |
| K230651 |
06/07/2023 |
BD BBLÖ Sensi-DiscÖ Lefamulin 20╡g (LMU-20) |
Becton, Dickinson and Company |
Katherine Cicala |
| K212733 |
06/06/2023 |
Diode laser therapy device |
Beijing Star New Tech Co., Ltd. |
Liang ZhongDong |
| K231406 |
06/14/2023 |
ClearumTM HS |
Bellco Srl |
Rekha Roveri |
| K231368 |
06/09/2023 |
Bemer Therapy System Evo |
Bemer INT AG |
Sandra Schwarzenberger |
| K231485 |
06/21/2023 |
iLet« ACE Pump |
Beta Bionics, Inc. |
Liz Cooper |
| K222466 |
06/30/2023 |
AirTom |
Bilab |
Sang Keun Lee |
| K231635 |
06/06/2023 |
A-Line Advanced |
Biocetec Co., Ltd |
Hee Sue Jin |
| K230905 |
06/09/2023 |
OrthoPulse 2.0E (OPi2E-100) |
Biolux Technology GmbH |
Daniela Penn |
| K222378 |
06/26/2023 |
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K222142 |
06/24/2023 |
BR SLA Type Implant System |
Biotem Co., Ltd. |
Hong Koo Yeo |
| K222144 |
06/14/2023 |
IR SLA Type Implant System |
Biotem Co., Ltd. |
Hong Koo Yeo |
| K231314 |
06/02/2023 |
Fine OsteotomyÖ |
BodyCad Laboratories, Inc. |
Nadine Adia |
| K210924 |
06/28/2023 |
e-Celsius Medical System |
BodyCAP |
SΘbastien Moussay |
| K231549 |
06/29/2023 |
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System |
Boston Scientific Corporation |
Jotham Moon |
| K230706 |
06/27/2023 |
EMBOLDÖ Soft Detachable Coil System |
Boston Scientific Corporation |
Laura Judge |
| K231533 |
06/21/2023 |
Habib EndoHPB |
Boston Scientific Corporation |
Carter Navarro |
| K223469 |
06/15/2023 |
WallFlexÖ Biliary RX Stent System |
Boston Scientific Corporation |
Alexis Erazo |
| K230759 |
06/13/2023 |
SafeLan« (2 models/SafeLan 26G, SafeLan 30G), SafeLan«-Pro (1 model/SafeLan«-Pro) |
Bosungmeditech Co., Ltd. |
Yang Ho Song |
| K223676 |
06/01/2023 |
SomniCheck |
BrainMatterZ, LLC |
Kevin Wilson |
| K223555 |
06/01/2023 |
Brainomix 360 e-CTP |
Brainomix Limited |
Gwilym Owen |
| K213611 |
06/07/2023 |
Fenom Pro |
CAIRE Diagnostics Inc. |
Ryan Leard |
| K230990 |
06/01/2023 |
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) |
Candela Corporation |
Danielle Gibboney |
| K223376 |
06/21/2023 |
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) |
Cardinal Health 200, LLC |
Emily Hunter |
| K231075 |
06/20/2023 |
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) |
Carl Zeiss Meditec Inc |
Chaitali Gawde |
| K230309 |
06/21/2023 |
Intra-Operative Positioning System (IOPS«) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) |
Centerline Biomedical, Inc. |
Amanda Shade |
| K231042 |
06/08/2023 |
Disposable Laparoscopic Trocar |
Changzhou Ankang Medical Instruments Co., Ltd. |
Tingting Cao |
| K230456 |
06/30/2023 |
SGM Femoral Nail System |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
Jing Huang |
| K223890 |
06/16/2023 |
NAJA Gastrointestinal Catheter |
Chess Medical Inc. |
Dr. Yen-I Chen |
| K223135 |
06/30/2023 |
AblatePal Radiofrequency Ablation System |
Compal Electronics, Inc |
Casper Chen |
| K230329 |
06/06/2023 |
F3D Interbody System |
Corelink, LLC |
Steven Mounts |
| K223074 |
06/02/2023 |
CorNeat EverPatch |
CorNeat Vision Ltd. |
Gerry Tal |
| K230261 |
06/06/2023 |
Gnesis EMS Plus |
Creative Fitness Developments S.L. |
Jose Luis Delgado |
| K223138 |
06/26/2023 |
AB1 Electrosurgical Instrument, Creo Electrosurgical System |
Creo Medical Ltd. |
Tiffany Powell |
| K213652 |
06/28/2023 |
Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) |
Cresilon, Inc. |
Hassaan W. Ahmad |
| K230381 |
06/07/2023 |
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator |
CS Medical LLC |
Kendall Ashe |
| K231359 |
06/09/2023 |
RODINÖ Expandable Lumbar Cage System |
CTL Medical Corporation |
Sean Suh |
| DEN220028 |
06/06/2023 |
Cue COVID-19 Molecular Test |
Cue Health Inc. |
Roderick Castillo |
| K223558 |
06/22/2023 |
CUVIS-spine |
Curexo, Inc. |
Sujin Yang |
| K231232 |
06/28/2023 |
Curiteva Laminoplasty System |
Curiteva, Inc. |
Eric Linder |
| K230660 |
06/06/2023 |
AviClear Laser System |
Cutera, Inc. |
Amogh Kothare |
| K231199 |
06/16/2023 |
Solar Lumbar Interbody Fusion System |
DeGen Medical |
Craig Black |
| K230633 |
06/05/2023 |
APOLLO ADVANTAGE Nitrile Examination Gloves |
Dell Corning Corporation |
Sam Chebeir |
| K230410 |
06/23/2023 |
DD medical polymers (PMMA) |
Dental Direkt GmbH |
Patrick Berz |
| K231202 |
06/22/2023 |
QuickRayPRO |
Denterprise International Inc. |
Claude Berthoin |
| K212183 |
06/07/2023 |
STA R Max 3, STA Compact Max 3 |
Diagnostica Stago SAS |
Pauline Vasselon |
| K231360 |
06/07/2023 |
Ambra PACS |
DICOM Grid dba Ambra Health |
Ashley Brown |
| K231264 |
06/30/2023 |
Easy On Universal Glaze & Stain |
Doctus Global |
Beom-jin Choi |
| K230374 |
06/29/2023 |
Coronary Dilatation Balloon Catheter (VesPenetrator«), Coronary Dilatation Balloon Catheter (VesTraveler«), Coronary Dilatation Balloon Catheter (VexPander«) |
Dongguan TT Medical, Inc |
Yuying Bi |
| K222822 |
06/14/2023 |
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) |
Draegerwerk AG & Co. KGaA |
Jan Upmeier |
| K223694 |
06/30/2023 |
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) |
Duearity AB |
Anneli Johansson |
| K230225 |
06/05/2023 |
DynaFlex Clear Brackets & Buttons |
Dyna Flex |
Matthew Malabey |
| K230337 |
06/29/2023 |
EarliPoint |
EarliTec Diagnostics, Inc |
Ryan Bormann |
| K230057 |
06/08/2023 |
Acumen Hypotension Prediction Index (HPI) Algorithm |
Edwards Lifesciences LLC |
Varad Raghuwanshi |
| K223865 |
06/09/2023 |
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor |
Edwards Lifesciences, LLC |
Sara Pesian |
| K231309 |
06/02/2023 |
SCAR 3 |
El.en Electroinc Engineering Spa |
Paolo Peruzzi |
| K222323 |
06/23/2023 |
Black Diamond |
Elevate Oral Care, LLC |
Steve Pardue |
| K223822 |
06/02/2023 |
ACTIVBRAIDÖ |
Embody, Inc. |
Brianna Schehr |
| K222592 |
06/23/2023 |
AltiVate« Anatomic Shoulder AG e+Ö with Markers |
Encore Medical, L.P |
Michael Siano |
| K230876 |
06/27/2023 |
RI.KNEE Adjustable Tibia Cut Guide |
Enztec Limited |
Breanna Crowther |
| K230933 |
06/30/2023 |
REMI Remote EEG Monitoring System |
Epitel, Inc. |
Randy Parry |
| K231023 |
06/15/2023 |
ERBEJET« 2 System |
Erbe Elektromedizin GmbH |
Matthias Kollek |
| K230709 |
06/09/2023 |
Auryon Atherectomy System |
Eximo Medical Ltd. |
Yoel Zabar |
| K230497 |
06/22/2023 |
Bladder AI (AIBV01) |
Exo Inc |
Jacqueline Murray |
| K223357 |
06/16/2023 |
EyeArt v2.2.0 |
Eyenuk, Inc. |
Kaushal Solanki |
| K223855 |
06/06/2023 |
FEops HEARTguideTM, FEops HEARTguideTM ALPACA |
FEops nv |
Peter Mortier |
| K231267 |
06/30/2023 |
ClearTip |
Finemedix Co., Ltd. |
Seok-Jun Ma |
| K220703 |
06/16/2023 |
F&P 950 Respiratory Humidifier |
Fisher & Paykel Healthcare |
Reena Daken |
| K221436 |
06/29/2023 |
F&P 950 Accessory Breathing Circuit Kits |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K231101 |
06/29/2023 |
Flume Catheter |
Flume Catheter Company, Ltd. |
Roger Holmes |
| K220301 |
06/02/2023 |
Volumat Line |
Fresenius Kabi |
Keith Dunn |
| K221121 |
06/16/2023 |
Volumat Polyethylene I.V. Administration Set |
Fresenius Kabi |
Jason Ma |
| DEN220078 |
06/09/2023 |
Eroxon |
Futura Medical Developments Limited |
Rachael Hawken |
| K223801 |
06/05/2023 |
FX V135(TM) Shoulder Prosthesis |
FX Shoulder USA, Inc |
Cory Trier |
| K230346 |
06/20/2023 |
Voluson SWIFT; Voluson SWIFT+ |
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC |
Bryan Behn |
| K221888 |
06/12/2023 |
Genadyne Hybrid Foam Dressings |
Genadyne Biotechnologies, Inc. |
Saiken Ho |
| K222702 |
06/02/2023 |
RGS; RGS Mini |
Genesis Air, Inc. |
Dan Briggs |
| K230718 |
06/15/2023 |
UTC 3mL Medication Cartridge |
Gilero, LLC |
Jessica Czamanski |
| K230991 |
06/30/2023 |
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E |
Given Imaging Ltd. (Medtronic) |
Breanna Hessler |
| K230397 |
06/12/2023 |
Cut Screw - Percutaneous Compression Screw |
GM Dos Reis Industria e Comercio Ltda |
Guilherme Esteves Pontes |
| K223374 |
06/30/2023 |
Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Jerry Fan |
| K230827 |
06/01/2023 |
HardyDisk AST Rezafungin 5╡g (RZF5) |
Hardy Diagnostics |
Anna Klavins |
| K222961 |
06/02/2023 |
Harvest Conceal ZR Block Out |
Harvest Dental Products, LLC |
Colleen Boswell |
| K231045 |
06/16/2023 |
Healgen URS Test Strips |
Healgen Scientific LLC |
Jianqiu Fang |
| K230617 |
06/01/2023 |
Surgical Face Mask (L 175*95mm) |
Henan Chaoya Medical Equipment Co., Ltd. |
Ruihua Miao |
| K230952 |
06/02/2023 |
Triathlon« Total Knee System - Triathlon« Pro Posterior Stabilized (PS) Femoral Component |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
Jane Guo |
| K222999 |
06/16/2023 |
Surgical Gown |
Hubei Woozon Healthcare Co.,Ltd. |
Li Chunlin |
| K223718 |
06/05/2023 |
HandXÖ Self-Righting Needle Holder |
Human Xtensions Ltd. |
Maija Wallenstein |
| K230536 |
06/14/2023 |
Single-use Flexible Rhinolaryngoscope; Digital Video Monitor |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K222727 |
06/02/2023 |
i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) |
i3 Membrane GmbH |
Stephan Brinke-Seiferth |
| K223646 |
06/16/2023 |
IB Lab LAMA |
IB Lab GmbH |
Richard Ljuhar |
| K230861 |
06/27/2023 |
VADER« Pedicle System Navigated Instruments |
Icotec ag |
Marina Hess |
| K230112 |
06/13/2023 |
CAC Software |
Imbio, Inc. |
Kay Sisavath |
| K223535 |
06/20/2023 |
SMARTbase Abutment System |
Implant Direct Sybron Manufacturing LLC |
Reina Choi |
| K223103 |
06/20/2023 |
BethaLoc« stem cementless HA |
implantcast Gmbh |
Juliane Hoppner |
| K223929 |
06/01/2023 |
LagunaÖ Clot Retriever System and MalibuÖ Aspiration Catheter System (Laguna Thrombectomy System) |
Innova Vascular, Inc. |
Ryan Kenney |
| K213754 |
06/12/2023 |
SpiroHome Personal, SpiroHome Clinic |
Inofab Saglik Teknolojileri A.S |
Deniz Sarp |
| K230052 |
06/30/2023 |
Inogen Rove 6 |
Inogen, Inc |
Sandra LeClair |
| K223083 |
06/22/2023 |
Straumann SLActive labeling changes |
Institut Straumann AG |
Ana Vianna |
| K223187 |
06/23/2023 |
HemosIL Liquid Anti-Xa |
Instrumentation Laboratory Co. |
Carol Marble |
| K231031 |
06/21/2023 |
ACL TOP Family 70 Series |
Instrumentation Laboratory Company |
Carol Marble |
| K223258 |
06/15/2023 |
TNI Clear-GuardÖ 3 angled breathing filter (1545020) |
Intersurgical Ltd. |
Ivan Seniut |
| K231212 |
06/21/2023 |
da Vinci E-200 Electrosurgical Generator |
Intuitive Surgical |
Shamsa Karimi |
| K230444 |
06/22/2023 |
Talee, Talee PostOp |
Invent Medical USA, LLC |
Jiri Rosicky |
| DEN220048 |
06/16/2023 |
Neoasis |
Invictus Medical, Inc. |
George Hutchinson |
| K222932 |
06/22/2023 |
INVOcell Intravaginal Culture System |
INVO Bioscience |
Steve Shum |
| K231596 |
06/30/2023 |
IOB Temperature Management System |
IOB Medical Inc |
Jonathan Kovach |
| K230635 |
06/02/2023 |
Pen Needle |
Jiangsu Caina Medical Co., Ltd. |
Camel Zhou |
| K223638 |
06/23/2023 |
Neodent Implant System - Helix Short Implant System |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Barbara Uzae |
| K230762 |
06/15/2023 |
EDEN Spinal Fixation MIS System |
JMT Co., Ltd. |
Sang-Ok Nam |
| K230359 |
06/23/2023 |
KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle |
KARL STORZ Endoscopy America, Inc |
Michael Block |
| K230573 |
06/13/2023 |
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) |
Kossan International Sdn Bhd |
Cho Sow Fong |
| K231636 |
06/27/2023 |
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. |
L&K BIOMED Co., Ltd. |
Katherine Kim |
| K230469 |
06/30/2023 |
Compact Wearable Pump |
Lansinoh Laboratories |
Lindsay Ewers |
| K230015 |
06/16/2023 |
OmniBoneÖ Bone Marrow Biopsy Kit with Power Driver, OmniBoneÖ Bone Biopsy Kit with Power Driver |
Laurane Medical SAS |
Laurent Fumex |
| K230498 |
06/05/2023 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K222492 |
06/27/2023 |
Hope&Her Vaginal Dilators |
Lujena, Inc. |
Troy Gemmer |
| K222790 |
06/14/2023 |
F65 Laser System |
Lumenis Be, Ltd. |
Shlomit Segman |
| K230917 |
06/30/2023 |
FebriDx Bacterial / Non-bacterial Point of Care Assay |
Lumos Diagnostics, Inc. |
Sue Hibbeln |
| K222450 |
06/09/2023 |
LVIS NeuroMatch |
LVIS Corporation |
William Antilla |
| K223498 |
06/01/2023 |
Radius VSM and Accessories |
Masimo Corporation |
Kertana Shankar |
| K230518 |
06/23/2023 |
HydraDose Vaginal Suppositories |
MD Labs LLC |
Harout Achekian |
| K231037 |
06/09/2023 |
MyKnee UNI-ST |
Medacta International S.A. |
Stefano Baj |
| K230971 |
06/02/2023 |
APTUS« 3.5 TriLock Straight Plates |
Medartis AG |
Claudia De Santis |
| K223556 |
06/16/2023 |
DeepCatch |
MEDICALIP Co., Ltd |
Jun-sik Yoon |
| K223048 |
06/23/2023 |
Medisystem Pacs |
Medilab Manutencao E Sitemas Ltda |
Jorge Millan |
| K220955 |
06/23/2023 |
Hudson RCI Variable concentration Large Volume Nebulizer (1770) |
Medline Industires, Inc. |
Nicole Schaffer |
| K223100 |
06/27/2023 |
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) |
Medline Industries, Inc |
Nichole Schaffer |
| K230214 |
06/02/2023 |
Huma RPM (RPM) |
Medopad Inc |
Mani Shanmugham |
| K231090 |
06/15/2023 |
Zevo Anterior Cervical Plate System |
Medtronic Sofamor Danek USA, Inc. |
Scott P. Baker |
| K230156 |
06/30/2023 |
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter |
Medtronic Vascular |
Shalin Parikh |
| K230944 |
06/30/2023 |
MeMed BV |
MeMed Diagnostics Ltd. |
Efrat Hartog-David |
| K230075 |
06/28/2023 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K |
Microlife Intellectual Property GmbH |
Ariel Wang |
| K230473 |
06/15/2023 |
IPL Hair Removal Device Models: MLY-T069 |
Miley Technology(Hebei) Co., Ltd. |
Hualing Wang |
| K223722 |
06/28/2023 |
MIO Blood Glucose Monitoring System |
Mio Labs Inc. |
Mark Qian |
| K230369 |
06/23/2023 |
EUROPAÖ Navigated Instruments |
MiRus LLC |
Jordan Bauman |
| K231117 |
06/23/2023 |
neXus Ultrasonic Surgical Aspirator System |
Misonix, LLC, a Bioventus Company |
John Salerno |
| K230888 |
06/02/2023 |
Titanium Turbine |
Nakanishi Inc. |
Masaaki Kikuchi |
| K230728 |
06/09/2023 |
JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
Donny Lee |
| K231170 |
06/07/2023 |
C350/C350G LCD Monitor; M550/M550G LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Donny Lee |
| K230936 |
06/02/2023 |
Anatomic PEEKÖ Cervical Fusion System with Nanotechnology |
Nanovis LLC |
Brian More |
| K231153 |
06/23/2023 |
Neuhat Hair Growth System; ibeauty.com Laser Cap |
Nature Incredible Inc |
John Lee |
| K230185 |
06/01/2023 |
ANT-X System |
NDR Medical Technology Pte. Ltd. |
Ng Ka Wei |
| K231349 |
06/06/2023 |
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) |
Nephron Nitrile, LLC. |
Lou Kennedy |
| K223047 |
06/29/2023 |
NeuroSwift Pro |
Neurobit Technologies Co., Ltd. |
Chun-Chen Yang |
| K223447 |
06/01/2023 |
OmniTom Elite |
NeuroLogica Corporation, a subsidiary of Samsung |
Ninad Gujar |
| K231350 |
06/08/2023 |
OCD MT Cap (85-00397-000) |
Neuronetics |
Amanda Pentecost |
| K230514 |
06/16/2023 |
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series |
Nikkiso Co., Ltd. |
Satoko Hina |
| K230502 |
06/09/2023 |
Ear Pressure Relief Device(Model:ER813B) |
Ningbo Albert Novosino Co., Ltd. |
Victor Zhou |
| K222906 |
06/16/2023 |
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 |
Ningbo Maxcon Medical Technology Co., Ltd. |
Puhai Ma |
| K222905 |
06/01/2023 |
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) |
Ningbo Maxcon Medical Technology Co., Ltd. |
Puhai Ma |
| K231110 |
06/16/2023 |
Manual Wheelchair (A006) |
Ningbo Shenyu Medical Equipment Co.,Ltd. |
Ding Jianjun |
| K231219 |
06/27/2023 |
NobelZygoma PureSetÖ Tray |
Nobel Biocare Services AG |
Bernice Jim |
| K220498 |
06/09/2023 |
NovoGen Wound Matrix |
Novabone Products, LLC |
Ed Horton |
| K230727 |
06/05/2023 |
SPY Portable Handheld Imaging (SPY-PHI) System |
Novadaq Technologies ULC (a part of Stryker) |
Cara Cahill |
| K223033 |
06/21/2023 |
Tixel« 2 System |
Novoxel Ltd. |
Omri Findler |
| K230894 |
06/16/2023 |
NuVasive Modulus ALIF System |
NuVasive, Incorporated |
Alexander Stevens |
| K223091 |
06/09/2023 |
CT Perfusion V1.0 |
Olea Medical |
Nathalie Palumbo |
| K223532 |
06/06/2023 |
Olea S.I.A. Neurovascular V1.0 |
Olea Medical |
Nathalie Palumbo |
| K222861 |
06/15/2023 |
EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 |
Olympus Medical Systems Corporation |
Shinichiro Kawachi |
| K220117 |
06/06/2023 |
ARC Intensive Care Information System (ARC System) |
Ordinatrum Solutions |
Ali Yasin Ozturk |
| K230567 |
06/13/2023 |
OptiVuÖ ROSA« MxR |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Mona Mansouri |
| K230595 |
06/29/2023 |
OsteoCentric ACL Fixation System |
OsteoCentric Technologies |
Todd Evans |
| K231322 |
06/07/2023 |
Fix2Lock(PEEK Self Punching) |
Osteonic Co., Ltd. |
Da Kyung Ham |
| K223248 |
06/21/2023 |
Tablo« Hemodialysis System |
Outset Medical, Inc. |
Saket Bhatt |
| K231124 |
06/27/2023 |
Unistik« 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) |
Owen Mumford Ltd |
Darren Mansell |
| K223854 |
06/30/2023 |
Unistik« ShieldLock, Unistik VacuFlip |
Owen Mumford Ltd |
Darren Mansell |
| K222597 |
06/16/2023 |
BabySat 3 |
Owlet Baby Care, Inc. |
Tammy Lavery |
| K230505 |
06/09/2023 |
OrthopantomographÖ OP 3D LX |
Palodex Group OY |
Frank Ray |
| K222762 |
06/08/2023 |
SIDDHARTH-II;IMPACT |
Panacea Medical Technologies Pvt Ltd |
Valli G. |
| K222018 |
06/02/2023 |
Breathe+ |
PEEP Medical LLC dba GO2 Devices |
Paul Dryden |
| K223918 |
06/08/2023 |
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub |
Philips Medical Systems Nederland B.V. |
Jeanette Becker |
| K230993 |
06/20/2023 |
CODAÖ Anterior Cervical Plate System |
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech |
Alicia Kaufman |
| K213253 |
06/30/2023 |
Pixyl.Neuro |
Pixyl SA |
Senan Doyle |
| K231430 |
06/07/2023 |
Intimate Rose Vaginal Dilators |
Plus EV Holdings dba Intimate Rose |
Aaron Wilt |
| K231647 |
06/29/2023 |
XENOVIEW 3.0T Chest Coil |
Polarean, Inc. |
Neil Wadehra |
| K231469 |
06/21/2023 |
PAXgene« Blood DNA Tube |
PreAnalytiX GmbH |
Alexandra Kirby |
| K231347 |
06/09/2023 |
BruxZirÖ TintEFX Coloring Liquid |
Prismatik Dentalcraft, Inc. |
Nina Chiang |
| K230715 |
06/08/2023 |
Promisemed Safety Huber Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K230322 |
06/22/2023 |
SelectFlex Neurovascular Access System Family |
Q'apel Medical, Inc. |
Kim Ky |
| K223379 |
06/22/2023 |
Portable Oxygen Concentrator (Model: P2-E7, P2-E) |
Qingdao Kingon Medical Science and Technology Co., Ltd. |
Zhang Benrong |
| K231467 |
06/21/2023 |
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF |
Rayence Co., Ltd |
Kevin Kim |
| K230781 |
06/20/2023 |
Belle Sensilube |
RB Health (US) LLC |
Kaitlyn Chan |
| K230599 |
06/22/2023 |
TargetCoolÖ |
RecensMedical, Inc. |
Lee Yeonui |
| DEN200052 |
06/29/2023 |
KidneyIntelX.dkd |
Renalytix AI, Inc. |
Joe Hutson |
| K231459 |
06/20/2023 |
HepaFatSmart (V2.0.0) |
Resonance Health Analysis Services Pty Ltd |
Mitchell Wells |
| K231348 |
06/05/2023 |
Elecsys ▀-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF |
Roche Diagnostics |
Greg Mondics |
| K231306 |
06/01/2023 |
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems |
Roche Molecular Systems, Inc. |
Caroline Sobek |
| K222969 |
06/23/2023 |
FERTI-LILY Conception Cup |
Rosesta Medical BV |
Stal Robert |
| K230036 |
06/23/2023 |
Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) |
RTI Surgical, Inc |
Lynne Witkowski |
| K231466 |
06/12/2023 |
RxSight Insertion Device |
RxSight, Inc. |
Maureen O'Connell |
| K223143 |
06/26/2023 |
SAGICO Spinal System |
Sagico VA USA, LLC |
James G Gibson |
| K221827 |
06/23/2023 |
Mais Central Venous Catheter |
Saudi Mais Co. for Medical Products |
Salman Rashid |
| K230408 |
06/01/2023 |
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) |
SB-Kawasumi Laboratories, Inc. |
Shiro Agehama |
| K231131 |
06/22/2023 |
Diode Laser Body Sculpture Systems |
Shanghai Bele Medical Technology Co.,Ltd |
Jeremy Li |
| K223518 |
06/13/2023 |
iOrtho |
Shanghai EA Medical Instruments Co., Ltd. |
Jessica Luo |
| K201153 |
06/13/2023 |
Tisuthes e-PTFE Surgical Patch |
Shanghai Suokang Medical Implants Co., Ltd. |
Lixinhua Lixinhua |
| K230779 |
06/09/2023 |
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Shanxi Hongjin Plastic Technology Co., Ltd. |
Wu Zhigang |
| K231136 |
06/16/2023 |
Fitness Belt (Model: KLT-07) |
Shenzhen KeLuTongDa Industrial Co.,Ltd. |
Zhongliang Luo |
| K230776 |
06/09/2023 |
Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) |
Shenzhen Lutejiacheng Technology Co., Ltd. |
Athena Pan |
| K230768 |
06/09/2023 |
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
Tang Jing |
| K220107 |
06/16/2023 |
Mindray SV600 Ventilator, Mindray SV800 Ventilator |
Shenzhen Mindray Bio-medical Electronics Co.,LTD. |
Yanhong Bai |
| K223291 |
06/14/2023 |
Electronic Blood Pressure Monitor |
Shenzhen Pango Medical Electronics Co., Ltd. |
Xiaoyun Yang |
| K230176 |
06/29/2023 |
Upper Arm Blood Pressure Monitor |
Shenzhen Yolanda Technology Co., Ltd. |
Xuejun Wang |
| K221752 |
06/04/2023 |
Stella |
Shinhung MST CO., LTD. |
Sun Ho Lee |
| K231689 |
06/30/2023 |
iFuse TORQ« Implant System |
Si-Bone, Inc. |
Meirav Harsat |
| K221801 |
06/02/2023 |
ADVIA Centaur« Anti-Mⁿllerian Hormone (AMH) |
Siemens Healthcare Diagnostics Inc. |
Mey Vasquez |
| K223078 |
06/12/2023 |
Atellica« CH Diazo Direct Bilirubin (D_DBil) |
Siemens Healthcare Diagnostics Inc. |
Anthony Calabro |
| K220728 |
06/02/2023 |
vWF Ag |
Siemens Healthcare Diagnostics Products GmbH |
Petra Dissmann |
| K230421 |
06/16/2023 |
SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash |
Siemens Medical Solutions USA Inc. |
Clayton Ginn |
| K214124 |
06/08/2023 |
AlloX2 Pro Tissue Expanders |
Sientra, Inc. |
Denise Daljes |
| K220072 |
06/18/2023 |
Sinobot X1 |
Sinovation (Beijing) Medical Technology Co., Ltd |
Manman Xu |
| K230761 |
06/14/2023 |
TRIGEN META-NAIL Nail System |
Smith & Nephew Inc. |
Hiral Rathod |
| K230572 |
06/07/2023 |
AETOS Shoulder System |
Smith & Nephew, Inc. |
Patrick Hughes |
| K222792 |
06/08/2023 |
SNUCONE Tissue Level Implant System |
Snucone Co., Ltd. |
Song Ha Eun |
| K220907 |
06/16/2023 |
The iNAP One Sleep Therapy System |
Somnics Inc. |
Chung-Chu Chen |
| K230538 |
06/16/2023 |
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid |
Sonova AG |
Nelson Hu |
| K223361 |
06/10/2023 |
BMR 1900 PHISIO |
Sorin Group Italia S.R.L. |
Luigi Vecchi |
| K231145 |
06/13/2023 |
Axis Anterior Cervical Plate System |
Southern Medical (Pty) Ltd |
Dalene Styger |
| K230796 |
06/20/2023 |
Sparrow Ascent |
Spark Biomedical, Inc. |
Brent Croft |
| K230386 |
06/15/2023 |
SpassageQ |
Spass Inc. |
Yonghwan Kim |
| K230691 |
06/07/2023 |
HyperVueÖ Imaging System |
SpectraWAVE Inc |
Farzad Parsaie |
| K231252 |
06/30/2023 |
VentanaÖ L Spinal System |
Spinal Elements, Inc. |
Julie Lamothe |
| K230774 |
06/23/2023 |
PERLA« TL System; TEKTONA« HV US Bone Cement |
Spineart |
Franck Pennesi |
| K223717 |
06/15/2023 |
Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack |
STERIS Corporation |
Gregory Land |
| K223715 |
06/15/2023 |
Celerity Incubator |
STERIS Corporation |
Gregoy Land |
| K230930 |
06/30/2023 |
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System |
STERIS Corporation |
Anthony Piotrkowski |
| K230886 |
06/21/2023 |
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control |
Stryker Endoscopy |
Lauren Bentley |
| K230512 |
06/09/2023 |
Gamma4 System |
Stryker GmbH |
Cindy Leon |
| K222684 |
06/08/2023 |
XIA« 4.5 Spinal System, XIA« 4.5 Cortical Trajectory, XIA« 3 Spinal System, Serrato« Spinal System, XIA« Growth Rod Conversion Set, XIA« II Spinal System, XIA« Precision System, XIA« Anterior, Diapason« Spinal System, OpusÖ Spinal System, Radius« Spinal S |
Stryker Spine |
Sierra Mertz |
| K231489 |
06/21/2023 |
Sturdy Autoclave Super Microm |
Sturdy Industrial Co., Ltd |
Wolfgang Huang |
| K230446 |
06/07/2023 |
TiLink-L SI Joint Fusion System |
Surgentec, LLC |
Andrew Shoup |
| K231022 |
06/12/2023 |
PounceÖ Thrombectomy System |
Surmodics Inc. |
Holly Ramirez |
| K231002 |
06/07/2023 |
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) |
Suzhou Endophix Co., Ltd. |
Jaun Wu |
| K221540 |
06/14/2023 |
Synexis Sphere Rx |
Synexis, LLC |
Athena Hansen |
| K223067 |
06/14/2023 |
Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent |
Taewoong Medical Co., Ltd. |
Yongjin Kim |
| K230276 |
06/23/2023 |
TECHFIT DISRP« System |
TECHFIT Digital Surgery |
Angela Marφa Lema-PΘrez |
| K231691 |
06/29/2023 |
Phantom XL Insulated Dilators |
TeDan Surgical Innovations Inc. |
Lynne Davies |
| K230659 |
06/08/2023 |
Zionic Aesthetic |
TermoSalud |
Cristina Cifuentes Pantoja |
| K221411 |
06/23/2023 |
Surflo Winged Infusion Set |
Terumo Medical Products (Hangzhou) Co., Ltd. |
Brian Byrd |
| K211618 |
06/05/2023 |
Fluido Compact Blood and Fluid Warming System |
The Surgical Company International B.V. |
Inette Nieveen |
| K230293 |
06/09/2023 |
TheraFace Mask |
Therabody, Inc. |
CJ Frederick, III |
| K230935 |
06/30/2023 |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) |
Thermo Fisher Scientific |
Cynthia Knapp |
| K221024 |
06/20/2023 |
tremoflo C2 Airwave Oscillometry System |
Thorasys Thoracic Medical Systems, Inc. |
Paul Donnelly |
| K212734 |
06/06/2023 |
Diode laser therapy device |
TRIANGEL RSD LIMITED |
Zhao Fengdan |
| DEN220041 |
06/02/2023 |
Tristel Duo ULT |
Tristel Solutions Limited |
Julija Shabanova |
| K230867 |
06/26/2023 |
Bone Bolt System |
University of Utah, Department of Orthopaedics |
Wade Fallin |
| K223029 |
06/20/2023 |
Perfit CL |
Vatech mcis Co., Ltd. |
Kim Gyeong Rok |
| K230584 |
06/06/2023 |
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter |
Vein 360 LLC |
Suzanne Meyer |
| K230160 |
06/23/2023 |
VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E |
Vinno Technology (Suzhou) Co., Ltd. |
Cordelia Liu |
| K223917 |
06/17/2023 |
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P |
VINNO Technology (Suzhou) Co.,Ltd |
Cordelia Liu |
| K223920 |
06/17/2023 |
VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P |
VINNO Technology (Suzhou) Co.,Ltd |
Cordelia Liu |
| K222982 |
06/23/2023 |
Virtus Metabolic Monitor |
Virtus Technology ApS |
Leif Olesen |
| K222933 |
06/29/2023 |
MYAH |
VISIA Imaging S.r.l. |
Alessia Magnanini |
| K231185 |
06/23/2023 |
MapRT |
Vision RT Ltd |
Jade Dunphy |
| K231148 |
06/20/2023 |
ScleroSafeÖ 150 mm, ScleroSafeÖ 350 mm |
VVT Medical Ltd. |
Liron Tayeb |
| K231505 |
06/23/2023 |
GORE« ACUSEAL Vascular Graft |
W. L. Gore & Associates, Inc. |
Sarah Pastrnak |
| K230859 |
06/28/2023 |
Aneroid Sphygmomanometer |
Wenzhou Kangshun Medical Devices Co.,Ltd |
Eric Shi |
| K221311 |
06/21/2023 |
Antibacterial Bandage |
Winner Medical Co., Ltd. |
Yi Fu |
| K231461 |
06/16/2023 |
Smart Correction System (HA Half Pins) |
WishBone Medical, Inc. |
Kellie Myers |
| K223517 |
06/13/2023 |
Clear Aligner |
Wuxi EA Medical Instruments Technologies Limited. |
Jessica Luo |
| K223059 |
06/07/2023 |
Xenco Medical InterAlign Cervical Interbody System |
Xenco Medical, LLC |
Jason Haider |
| K231109 |
06/15/2023 |
Xerxes Hip Stem |
Xerxes Arthopedix LLC |
H Kurtis Biggs |
| K223522 |
06/20/2023 |
NC░ Thermometer (Gen 3), Model Number: NCTG3 |
Xiamen Intretech Inc. |
Sunny Sun |
| K223562 |
06/02/2023 |
Xpan Universal Trocar System |
Xpan Inc. |
Zaid Atto |
| K230506 |
06/21/2023 |
PureLift Pro Edition |
Xtreem Pulse |
Andrew Barile |
| K220198 |
06/28/2023 |
Medi Lift PLUS |
YA-MAN Ltd |
Jun Takada |
| K230992 |
06/09/2023 |
DJF Intravascular Administration Set |
Yangzhou Wei De Li Trade Co. Ltd |
Joyce Wu |
| K221488 |
06/26/2023 |
Z7 Zirconia Implant System |
Z7 LLC |
Gerald Andrew Kaminsky |
| K230731 |
06/14/2023 |
Zavation ALIF System |
Zavation Medical Products, LLC |
Frankie Cummins |
| K223019 |
06/23/2023 |
sam 2.0 Long Ultrasound Device |
ZetrOZ Systems, LLC |
Sabrina Lewis |
| K222001 |
06/08/2023 |
Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe |
Zhejiang CuraWay Medical Technology Co., Ltd. |
Xiaoyu Guan |
| K231320 |
06/05/2023 |
Zhenjiang Assure Mechanical Wheelchair,model:K1 |
Zhenjiang Assure Medical Equipment Co.,Ltd. |
Eric Shi |
| K231215 |
06/26/2023 |
IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S |
ZhongShan Qizhe Technology Co., Ltd. |
Gan Guiping |
| K223741 |
06/22/2023 |
Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) |
Zhuhai Pusen Medical Technology Co., Ltd. |
Changshen Wang |
| K223217 |
06/16/2023 |
Zynex Monitoring System, Model CM-1600 |
Zynex Medical, Inc. |
Donald Gregg |
