| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K232392 |
08/09/2023 |
CT Lung Ventilation Analysis Software (CT:V) |
4DMedical Limited |
Nichole Murray |
| K232386 |
08/09/2023 |
ILUMIENÖ OPTISÖ System, OPTISÖ Integrated System, OPTISÖ Mobile System, with AptiVueÖ Imaging Software version E.6 |
Abbott Medical |
Derek Pike |
| K232458 |
08/15/2023 |
JETiÖHydrodynamic Thrombectomy System |
Abbott Medical |
Maidy Cordova Audon |
| K232592 |
08/25/2023 |
CITRELOCK« DUO |
Acuitive Technologies, Inc. |
Matthew Poggie |
| K232440 |
08/14/2023 |
Adravision Perio |
Adra Corporation |
Yasaman Nematbakhsh |
| K232507 |
08/18/2023 |
Aerogen«Solo Nebulizer System |
Aerogen Ltd. |
Thelma Marley |
| K232301 |
08/01/2023 |
Define RF Microneedling System |
Aesthetic Management Partners |
Shlomo Assa |
| K232438 |
08/14/2023 |
Dental Glass Ceramics Blocks |
Aibodent Biotechnology Co., Ltd |
Qingliang Chen |
| K232645 |
08/30/2023 |
Airgle Room Air Purifier |
Airgle Corporation |
Jerry Liu |
| K232405 |
08/10/2023 |
ENDOFIX EXO |
AKTORmed GmbH |
Hanna Kafurke |
| K232454 |
08/14/2023 |
Viral Transport Media (VTM) |
ALB Luz |
Ana Luiza Bueno Luz |
| K232338 |
08/04/2023 |
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 |
Alicn Medical Shenzhen, Inc |
Fang Meisong |
| K232345 |
08/04/2023 |
ATEC Posterior Navigated Disc Prep Instruments |
Alphatec Spine, Inc. |
Sandy Gill |
| K232504 |
08/18/2023 |
Calibrate CCX Interbody System |
Alphatec Spine, Inc. |
Neha Mohindroo |
| K232413 |
08/10/2023 |
Fusion Robotic Navigation System |
Alphatec Spine, Inc. |
Sarah Braun |
| K232582 |
08/25/2023 |
Ambu« aScopeÖ 5 Broncho 4.2/2.2 Sampler Set |
Ambu A/S |
Eva Lind Rasmussen |
| K232544 |
08/22/2023 |
Apollo ESG NXT System, Apollo REVISE NXT System |
Apollo Endosurgery Inc. |
James Shene |
| K232443 |
08/14/2023 |
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
| K232522 |
08/18/2023 |
ARK Levetiracetam II Assay |
ARK Diagnostics, Inc. |
Dionne Labatore |
| K232416 |
08/11/2023 |
AUTION EYE AI-4510 Urine Particle Analysis System |
Arkray Inc. |
Shinya Nakajima |
| K232343 |
08/04/2023 |
AC3Ö Series IABP |
Arrow International, LLC |
Sheila Payzant |
| K232340 |
08/04/2023 |
Arthrex 2.4mm Knotless Hip SutureTak« Suture Anchor |
Arthrex Inc. |
Alex Underberg |
| K232290 |
08/01/2023 |
INTELLIO SHIFT System |
ArthroCare Corporation |
Jennifer Burns |
| K232560 |
08/23/2023 |
Angled Abutment |
Arum Dentistry Co., Ltd. |
Won-yi Choi |
| K232559 |
08/23/2023 |
C&B NFH Hybrid |
Arum Dentistry Co., Ltd. |
Boyeon Lim |
| K232627 |
08/29/2023 |
HotDog Warming Mattress + Return Electrode |
Augustine Temperature Management, LLC |
Garrett Augustine |
| DEN230055 |
08/25/2023 |
FSYXÖ Ocular Pressure Adjusting Pump (FSYXÖ OPAP) System |
Balance Ophthalmics, Inc. |
Gary Mocnik |
| K232467 |
08/15/2023 |
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine |
Baxter Healthcare Corporation |
Kristen Bozzelli |
| K232562 |
08/24/2023 |
PowerWire Radiofrequency Guidewire Kit |
Baylis Medical Technologies Inc. |
Stephanie Gallone |
| K232434 |
08/11/2023 |
BD VeritorÖ System for Rapid Detection of Flu A+B CLIA Waived Kit |
BD |
Michelle Bowerman |
| K232600 |
08/28/2023 |
DxFLEX Flow Cytometer; ClearLLab 10C Panels |
Beckman Coulter, Inc |
Stephanie Harlacz |
| K232532 |
08/21/2023 |
Nd:Yag Laser Therapy Systems |
Beijing UNT Technology Co., Ltd. |
Qianwen Sheng |
| K232320 |
08/03/2023 |
iSR`obot Mona Lisa 2.0 |
Biobot Surgical Pte Ltd |
Lim Yan Shin |
| K232662 |
08/31/2023 |
BNLE Hydrophilic Jacketed Peripheral Guidewire |
Biomerics NLE |
Maggie Goshert |
| K232395 |
08/09/2023 |
ETEST« Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ╡g/mL), ETEST« SUD |
bioMΘrieux |
Sophie Quiblier |
| K232521 |
08/18/2023 |
ExactechGPS« Total Ankle Application |
Blue Ortho |
Matthieu Coic |
| K232653 |
08/31/2023 |
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX |
Blue Sky Bio, LLC |
Albert Zickmann |
| K232633 |
08/30/2023 |
Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter |
Boston Scientific |
Lingling Guo |
| K232635 |
08/30/2023 |
IceSeed 1.5 CX 90║ Needle (H7493967433170); IceSeed 1.5 CX S 90║ Needle (H7493967233100) |
Boston Scientific |
Jake Burke |
| K232651 |
08/31/2023 |
BLAZERÖ Dx-20 Bidirectional Steerable Diagnostic Catheter |
Boston Scientific Corporation |
Laura Wotta |
| K232496 |
08/17/2023 |
Brainomix 360 Triage Stroke |
Brainomix Limited |
Zsolt Szrnka |
| K232601 |
08/28/2023 |
BroncTruÖ Transbronchial Access Tool |
Broncus Medical, Inc |
Charles Ogbonna |
| K232603 |
08/28/2023 |
CamAPS FX |
CamDiab Ltd. |
Roman Hovorka |
| K232298 |
08/01/2023 |
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl |
Canon Inc. |
Shigeo Watanabe |
| K232526 |
08/21/2023 |
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 |
Canon Medical Systems Corporation |
Paul Biggins |
| K232341 |
08/04/2023 |
CarboClear« Pedicle Screw System |
Carbofix Orthopedics Ltd. |
Hila Wachsler Avrahami |
| K232480 |
08/16/2023 |
ProtekDuo Veno-Venous Cannula Sets |
CardiacAssist, Inc. |
Mariah McMinn |
| K232445 |
08/14/2023 |
CSF-4 (CSF-4) |
CardiacSense |
Benita Lanzer |
| K232502 |
08/18/2023 |
Cocoon Convective Warming System, Model CWS7000 |
Care Essentials Pty Ltd |
Abhay Sinha |
| K232583 |
08/25/2023 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K232394 |
08/09/2023 |
Internal Locking Plate and Screw Fixation System |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
Jing Huang |
| K232661 |
08/31/2023 |
Myocardial Strain Software Application |
Circle Cardiovascular Imaging |
Sydney Toutant |
| K232379 |
08/08/2023 |
PREVENT Kit |
Clear Choice Therapeutics |
Bret Batchelder |
| K232429 |
08/11/2023 |
Titan Dental Design |
ClearAdvance, LLC |
Frank Puig |
| K232426 |
08/11/2023 |
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts |
Conformis Inc |
Mary Kruitwagen |
| K232665 |
08/31/2023 |
GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) |
ConvaTec |
Kim Jones |
| K232646 |
08/30/2023 |
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) |
Cook Biotech Incorporated |
Christopher Lotzow |
| K232357 |
08/07/2023 |
Copan Universal Transport Medium (UTM-RT) System |
Copan Italia S.p.A. |
Silvia Caprini |
| K232565 |
08/24/2023 |
UriSpongeÖ |
Copan Italia S.p.A. |
Silvia Caprini |
| K232573 |
08/25/2023 |
INFINITIÖ Ambi Angiographic Catheter |
Cordis US Corp. |
Zheng Wang |
| K232548 |
08/23/2023 |
Corsano CardioWatch 287-2 System |
Corsano Health B.V. |
Peter Stas |
| K232546 |
08/23/2023 |
Meta G UCLA Abutment |
Cowellmedi Co., Ltd. |
Haejun Lee |
| K232643 |
08/30/2023 |
Cue COVID-19 Molecular Test |
Cue Health Inc. |
Sharon Young |
| K232367 |
08/08/2023 |
cmAngio« V1.0 |
CureMetrix, Inc. |
Kevin Harris |
| K232316 |
08/03/2023 |
DEKA Infusion System, DEKA Administration Set |
DEKA Research and Development |
Paul Smolenski |
| K232303 |
08/01/2023 |
ATTUNE« Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUMÖ 3DP Technology |
DePuy Ireland UC |
Kathy Boggs |
| K232556 |
08/23/2023 |
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System |
Depuy Ireland UC |
Susan Mullane |
| K232448 |
08/14/2023 |
FREEPRINT« splintmaster |
Detax GmbH |
Markus Stratmann |
| K232615 |
08/28/2023 |
LumiMARKÖ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARKÖ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARKÖ Biopsy Site Marker (LM0215R (Rose shape)) |
Devicor Medical Products, Inc. |
Katy Austin |
| K232487 |
08/17/2023 |
Provecta 3D Prime and Provecta 3D Prime Ceph |
Durr Dental SE |
Oliver Lange |
| K232336 |
08/04/2023 |
ES Series V2 |
E-Scopics |
Claude Cohen Bacrie |
| K232294 |
08/01/2023 |
HemoSphere Alta Advanced Monitoring Platform; HemoSphere AltaÖ Advanced Monitor (Smart Recovery); HemoSphere AltaÖ Advanced Monitor (Cardiac); HemoSphere AltaÖ Advanced Monitor (All-on-One) |
Edwards Lifesciences, LLC |
Varad Raghuwanshi |
| K232424 |
08/11/2023 |
CurrentBody Skin RF |
EL Global Trade Ltd. |
Sivan Fishman |
| K232334 |
08/04/2023 |
DEKA SIMON |
El.En. S.p.A. |
Paolo Peruzzi |
| K232300 |
08/01/2023 |
ElastiMed SACS |
ElastiMed Ltd. |
Omer Zelka |
| K232536 |
08/21/2023 |
Soldier Microcatheter |
Embolx, Inc. |
Louise Musante |
| K232596 |
08/25/2023 |
EndoGI S-Path Biliary Stent System |
EndoGI Medical, Ltd. |
Omri Naveh |
| K232518 |
08/18/2023 |
EndoSound Vision System; EVS |
Endosound, Inc |
Patrick Herriman |
| K232327 |
08/03/2023 |
Endorail |
Endostart s.r.l. |
Alessandro Tozzi |
| K232632 |
08/30/2023 |
Racz Neurostat RF Generator |
Epimed International |
Preston Frasier |
| K232313 |
08/02/2023 |
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) |
Ethicon Endo Surgery, LLC. |
Lakrisha Tinner |
| K232383 |
08/08/2023 |
iPhysio« System |
Euroteknika |
Yoann Delatre |
| K232641 |
08/30/2023 |
Neorad Pacs (Neorad Pacs) |
Everrtech Software PVT LTD |
Josh Baker |
| K232432 |
08/11/2023 |
E3DÖ-A Interbody System |
Evolution Spine |
Todd Wallenstein |
| K232501 |
08/17/2023 |
AI Platform (AIP001) |
Exo Inc |
Jacqueline Murray |
| K232578 |
08/25/2023 |
VASSALLO GT 018 G12; VASSALLO GT 018 G30 |
Filmec Co. Ltd. |
Toshiya Osawa |
| K232574 |
08/25/2023 |
VASSALLO GT Crossing14 |
Filmec Co. Ltd. |
Toshiya Osawa |
| K232545 |
08/22/2023 |
The SensiTox B. anthracis Toxin Test |
First Light Diagnostics, Inc. |
Joanne Spadoro |
| K232484 |
08/16/2023 |
KeyLiftÖ Expandable Interlaminar Stabilization System |
FloSpine |
Peter Harris |
| K232551 |
08/23/2023 |
EM-07 Cordless Endo Motor |
Forum Engineering Technologies (96) Ltd. |
Nissim Oz |
| K232464 |
08/15/2023 |
VereSee Optical Veres Needle System |
Freyja Healthcare, LLC |
Ronald Adams |
| K232314 |
08/02/2023 |
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) |
Fujifilm Healthcare Americas Corporation |
Chaitrali Kulkarni |
| K232292 |
08/01/2023 |
Peridot-EX Expandable Intervertebral Body Fusion System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K232346 |
08/04/2023 |
Digital Expert Access with Remote Scanning |
GE Healthcare |
Allena Holzworth |
| K232344 |
08/04/2023 |
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR |
GE Medical Systems SCS |
Hubert Welsch |
| K232381 |
08/08/2023 |
LOGIQ Totus |
GE Medical Systems Ultrasound and Primary care Diagnostics, |
Bryan Behn |
| K232569 |
08/24/2023 |
CAREMIBRAIN |
General Equipment for Medical Imaging, S.A. |
Maria Climent |
| K232599 |
08/28/2023 |
TransForm McCarthy Mitral Annuloplasty Ring (TF) |
Genesee Biomedical Inc |
Woodrow Mathison |
| K232318 |
08/03/2023 |
VICTORYÖ Lumbar Plate System |
Globus Medical, Inc |
Jennifer Antonacci |
| K232444 |
08/14/2023 |
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs |
Grand Work Plastic Products Co., Ltd. |
Wu Yuli |
| K232621 |
08/29/2023 |
Blood pressure monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Jerry Fan |
| K232466 |
08/15/2023 |
Electric Breast Pump, model: YM-8166 |
Guangdong Youmeng Electrical Technology Co., Ltd. |
Liu Zongjun |
| K232659 |
08/31/2023 |
Dochek« Multi-Drug Urine Test Cup Rx, Dochek« Multi-Drug Urine Test Cup |
Guangzhou Decheng Biotechnology Co., Ltd. |
Weifang Liu |
| K232439 |
08/14/2023 |
Electrical Stimulator System |
Gymmax Technology Shenzen Co., Ltd. |
Benson Wang |
| K232401 |
08/10/2023 |
Disposable Veress Needles |
Hangzhou Kangji Medical Instrument Co., Ltd. |
Martin Sun |
| K232604 |
08/28/2023 |
LYHER« Urine Marijuana (THC) Test Kit (Strip), LYHER« Urine Marijuana (THC) Test Kit (Cassette) |
Hangzhou Laihe Biotech Co., Ltd. |
Yaohua Chen |
| K232597 |
08/28/2023 |
LYHER« Urine Multi-Drug Test Kit(Cup), LYHER« Urine Multi-Drug Test Kit(Cassette), LYHER« Urine Multi-Drug Test Kit(Dipcard) |
Hangzhou Laihe Biotech Co., Ltd. |
Yaohua Chen |
| K232579 |
08/25/2023 |
Twoplus Applicator |
Hannah Life Technologies Pte Ltd. |
Prusothman M Sina Raja |
| K232377 |
08/08/2023 |
Healgen Rapid COVID-19 Antigen Test |
Healgen Scientific LLC |
Jinjie Hu |
| K232642 |
08/30/2023 |
AirKEE T900 |
HealKEE Medical Pte Ltd |
William Tao |
| K232356 |
08/07/2023 |
Laser Cap, Model: Hat-01 |
Hubei YJT Technology Co.,Ltd |
Jiali Xie |
| K232589 |
08/25/2023 |
Horos MDÖ |
iCat Solutions Ltd |
Georgios Michalopoulos |
| K232628 |
08/29/2023 |
VADER« Pedicle System |
icotec AG |
Marina Hess |
| K232371 |
08/08/2023 |
Actinia« hip stems |
implantcast, GmbH |
Juliane H÷ppner |
| K232613 |
08/28/2023 |
CT Cardiomegaly |
Innolitics, LLC |
Yujan Shrestha |
| K232328 |
08/03/2023 |
InsignisÖ Syringe Infusion System |
Innovative Health Sciences, LLC |
Phil Daetwyler |
| K232610 |
08/28/2023 |
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation |
Intuitive Surgical, Inc. |
Melissa S Gonzalez |
| K232331 |
08/04/2023 |
InVision Precision LVEF (LVEF) |
InVision Medical Technology Corporation |
David Ouyang |
| K232638 |
08/30/2023 |
FilteredFlo Warming Blankets |
IOB Medical Inc |
Jonathan Kovach |
| K232568 |
08/24/2023 |
IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories |
IPG Medical Corporation |
Samuel D Wade |
| K232436 |
08/14/2023 |
Rapid SDH |
iSchemaView, Inc. |
Jim Rosa |
| K232385 |
08/09/2023 |
OxiplexTS200 |
ISS Medical, Inc. |
Beniamino Barbieri |
| K232576 |
08/25/2023 |
Medical Nitrile Examination Gloves |
Jiangsu Complete Sincerity Medical New Materials Co., Ltd. |
Shangjun Xie |
| K232477 |
08/16/2023 |
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) |
Jiangxi AOV Maternity & Baby Products Co., Ltd. |
Huang Xueping |
| K232333 |
08/04/2023 |
Anti-bacterial bandage |
Jinhua Jingdi Medical Supplies Co., Ltd. |
Xiaojiang Hu |
| K232515 |
08/18/2023 |
Valkyrie Thoracic Fixation System |
JM Longyear Manufacturing, LLC d/b/a Able Medical Devices |
Katie Barron |
| K232586 |
08/25/2023 |
Rexious Spinal Fixation System, StateraÖ Spinal System, Statera-MÖ Spinal System |
K&J Consulting Corp. |
Jeena Mathai |
| K232572 |
08/24/2023 |
Kalitec Navigated Instrument System |
Kalitec Direct, LLC doing business as Kalitec Medical |
Winn Scott |
| K232293 |
08/01/2023 |
kallisio stentraÖ oral stent |
Kallisio, Inc |
Rajan Patel |
| K232486 |
08/16/2023 |
KARL STORZ Monopolar Resectoscopes with HF Cable |
Karl Storz SE & CO. KG |
Leigh Spotten |
| K232406 |
08/10/2023 |
KARL STORZ OR1Ö SCB CONTROL (WU300) |
Karl Storz SE & Co. KG |
Thomas Ostrowski |
| K232370 |
08/08/2023 |
Percutaneous Nephroscope System |
Karl Storz SE & Co. Kg |
Alita McElroy |
| K232593 |
08/25/2023 |
FITme Customized Silicone Implant |
Keosan Trading Co. |
Priscilla Chung |
| K232359 |
08/07/2023 |
Surgical face mask |
Kingstar Medical (Xianning) Co., Ltd. |
Fan Rong |
| K232588 |
08/25/2023 |
Aluna 2 |
Knox Medical Diagnostics |
Michael Raftery |
| K232461 |
08/15/2023 |
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; |
Kossan International Sdn Bhd |
Cho Sow Fong |
| K232347 |
08/04/2023 |
MagnetOs Granules |
Kuros Biosciences B.V. |
Hen Baron |
| K232311 |
08/02/2023 |
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System |
L&K Biomed Co., Ltd. |
Katherine Kim |
| K232571 |
08/24/2023 |
CATHTONGÖ II PICC Catheter |
L&Z US, Inc. |
James Li |
| K232594 |
08/25/2023 |
CATHTONGÖ II PICC Catheter |
L&Z US, Inc. |
James Li |
| K232564 |
08/24/2023 |
Align Studio |
Laon Medi Inc. |
Mina Yun |
| K232605 |
08/28/2023 |
Sacrix« Sacroiliac Joint Fusion Device System, Inspan« ScrewLES Fusion System, Invue« MAXÖ + Invue Inset Anterior Cervical Plate System, and FacetFuse« Screw Fixation System |
LESspine Innovations |
Vito Lore |
| K232611 |
08/28/2023 |
TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System |
Life Spine, Inc. |
Angela Batker |
| K232489 |
08/17/2023 |
VenusX |
LinaTech LLC |
Jonathan Yao |
| K232291 |
08/01/2023 |
Essenz HLM, Essenz ILBM |
LivaNova Deutschland GmbH |
Florian Goetz |
| K232639 |
08/30/2023 |
Apollo TMS Therapy System |
MAG & More GmbH |
Kerstin Haeringer |
| K232523 |
08/18/2023 |
Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% |
Mankind Pharma Limited |
Rajender Singh |
| K232389 |
08/09/2023 |
Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue |
Masimo Corporation |
Kertana Shankar |
| K232512 |
08/18/2023 |
Masimo W1 |
Masimo Corporation |
Sindura Penubarthi |
| K232324 |
08/03/2023 |
StealthFix Intraosseous Fixation System |
Medartis Inc. |
Chelsea Kozior |
| K232608 |
08/28/2023 |
Duo Hands-free Breast Pump |
Medela LLC |
Jenni Vescovo |
| K232404 |
08/10/2023 |
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES |
Medicon Hellas, S.A |
Sotia Mitropoulou |
| K232329 |
08/03/2023 |
Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter |
Medivators (A Subsidiary of STERIS Corporation) |
Nick Wang |
| K232492 |
08/17/2023 |
2.7 mm GRYPHONÖ Flex Knotless PEEK Anchor; 2.7 mm GRYPHONÖ Flex Knotless Biocomposite Anchor |
Medos International SARL |
Elizabeth P. Messana |
| K232321 |
08/03/2023 |
FlexCath ContourÖ Steerable Sheath |
Medtronic Inc. |
Kripa Pandya |
| K232570 |
08/24/2023 |
SteerantÖ Super Stiff Guidewire |
Medtronic Vascular |
Amy Sanders |
| K232417 |
08/11/2023 |
MR Q; MR Q SUPINE; MR Q SLT |
Meridian AG |
Eric Odenheimer |
| K232609 |
08/28/2023 |
Micro AceÖ Advanced Micro Access System |
Merit Medical Systems, Inc. |
Garry Courtney |
| K232299 |
08/01/2023 |
CeraPutty |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K232542 |
08/22/2023 |
Wedge XL Delivery Catheter |
MicroVention, Inc. |
Alick Tan |
| K232410 |
08/10/2023 |
SmartChest |
Milvue |
Oumaya Ibrahim |
| K232514 |
08/18/2023 |
MIM û Dose Analysis |
MIM Software Inc. |
Sydney Lindner |
| K232481 |
08/16/2023 |
RIGELÖ 3DR Anterior Cervical Corpectomy System |
MiRus, LLC |
Jordan Bauman |
| K232348 |
08/07/2023 |
RIGELÖ 3DR Standalone Anterior Cervical Interbody Fusion System |
MiRus, LLC |
Jordan Bauman |
| K232508 |
08/18/2023 |
Barrier EasyWarm Active Self-Warming Blanket |
Molnlycke Health Care US, LLC |
Megan Bevill |
| K232354 |
08/07/2023 |
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software |
Murata Vios, Inc. |
Amit Patel |
| K232415 |
08/11/2023 |
Nalu Neurostimulation System for Peripheral Nerve Stimulation |
Nalu Medical, Inc. |
Chelsea Gutierrez |
| K232528 |
08/21/2023 |
Protective Cap |
Neobiotech Co., Ltd. |
Yoeng Ku Hoe |
| K232558 |
08/23/2023 |
UroLift 2 ATC Advanced Tissue Control System |
NeoTract, Inc. |
Kelsey Krische |
| K232654 |
08/31/2023 |
Nephron NitrileÖ, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) |
Nephron Nitrile, LLC. |
Lou Kennedy |
| K232644 |
08/30/2023 |
neuro42 MRI System |
Neuro42, Inc. |
Abhita Batra |
| K232530 |
08/21/2023 |
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K232567 |
08/24/2023 |
Myriad SPECTRA Light Source |
NICO Corporation |
Megan Becker |
| K232388 |
08/09/2023 |
High Pressure Tubing |
Ningbo DIZEGENS Medical Science Co., Ltd. |
Zhang Wenwei |
| K232577 |
08/25/2023 |
Radial Compression Device |
Ningbo DIZEGENS Medical Science Co., Ltd. |
Zhang Wenwei |
| K232330 |
08/03/2023 |
Lancing System |
Ningbo Medsun Medical Co., Ltd. |
Liu Ping |
| K232648 |
08/31/2023 |
RODEO Telescopic Nail |
Orthofix SRL |
Elvira Taccarelli |
| K232533 |
08/21/2023 |
ROSA Partial Knee System |
Orthosoft d/b/a Zimmer CAS |
Rakhi Toravane |
| K232425 |
08/11/2023 |
SignatureÖ ONE System |
Orthosoft Inc. (d/b/a) Zimmer CAS) |
Nilam Dave |
| K232315 |
08/02/2023 |
Catalyst Bone Void Filler |
OssDsign AB |
Jonas Aberg |
| K232513 |
08/18/2023 |
X-Twist Biocomposite Suture Anchor |
Parcus Medical |
Calen Souther |
| K232649 |
08/31/2023 |
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses |
Pegavision Corporation |
Estela Lin |
| K232524 |
08/18/2023 |
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set |
Perfuze Ltd. |
Anne-Marie Gannon |
| K232657 |
08/31/2023 |
InnerView LC |
Perimetrics, Inc |
Alicia Mszyca |
| K232372 |
08/08/2023 |
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) |
Peters Surgical |
Ellen Henke-Knupp |
| K232491 |
08/17/2023 |
CT 5300 |
Philips Healthcare (Suzhou) Co., Ltd. |
An Shiguang |
| K232420 |
08/11/2023 |
Zenition 30 |
Philips Medical Systems Nederland BV |
Gyanendra Mani Tripathi |
| K232500 |
08/17/2023 |
Lumify Diagnostic Ultrasound System |
Philips Ultrasound |
Sudipta Chakrabarti |
| K232656 |
08/31/2023 |
BLU TOTALE (Model: ENEOB852) |
Premier North America Inc. |
Ellis Tamari |
| K232602 |
08/28/2023 |
3DMatrix Surgical Mesh |
PrintBio, Inc. |
Kevin Slawin |
| K232393 |
08/09/2023 |
BluTube« Dental Unit Water Purification Cartridge (BluTube«); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge |
ProEdge Dental Products, Inc. |
Mark Frampton |
| K232361 |
08/07/2023 |
Promaxo MRI System II |
Promaxo, Inc. |
Veronica Sanz |
| K232302 |
08/01/2023 |
Pocket III |
Quantel Medical |
Bruno Pages |
| K232286 |
08/01/2023 |
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument |
Quidel Corporation |
Ronald Lollar |
| K232325 |
08/03/2023 |
RAYSCAN a-Expert |
Ray Co., Ltd. |
Sooji Huh |
| K232287 |
08/01/2023 |
RAYSCAN a-Expert3D |
Ray Co., Ltd. |
Sooji Huh |
| K232618 |
08/29/2023 |
Aurora Surgiscope System |
Rebound Therapeutics Corporation |
Timothy Connors |
| K232595 |
08/25/2023 |
Kinos Axiom Total Ankle System |
restor3d |
Brianna Prindle |
| K232411 |
08/10/2023 |
JuggerKnot Soft Anchor OC |
Riverpoint Medical, LLC |
Becca DeFrancia |
| K232488 |
08/17/2023 |
Accu-Chek Safe-T-Pro Plus Lancing Device |
Roche Diabetes Care, Inc. |
Kacia Mills |
| K232509 |
08/18/2023 |
Accu-Chek Safe-T-Pro Uno Lancing Device |
Roche Diabetes Care, Inc. |
Kacia Mills |
| K232650 |
08/31/2023 |
KHEIRON« Spinal Fixation System, including patient specific K-ROD |
S.M.A.I.O |
Jean-Charles Roussouly |
| K232407 |
08/10/2023 |
Cautery Protective Actuation System (CPAS) |
Safer Surgeries Medical Devices, LLC |
Rowland Grattan |
| K232561 |
08/24/2023 |
Ripley Spinal Screw System by SAGICO |
Sagico VA USA, Llc |
James Gibson, PhD, CPA |
| K232619 |
08/29/2023 |
MATRIX HA PEEK Cervical IBF System |
Sapphire Medical Group |
Anthony Ruggiero |
| K232468 |
08/15/2023 |
SC Medica FFX |
SC Medica |
Camille Srour |
| K232566 |
08/24/2023 |
NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System |
SeaSpine Orthopedics Corporation |
Jacki Koch |
| K232495 |
08/17/2023 |
Sempulse Halo Vital Signs Monitor |
Sempulse Corporation |
Matt Barrera |
| DEN230052 |
08/09/2023 |
Eversense AP CGM System |
Senseonics, Incorporated |
Mukul Jain |
| K232516 |
08/18/2023 |
Sentec Digital Monitoring System (SDMS) tCOM+ |
Sentec AG |
Caroline Moller |
| K232355 |
08/07/2023 |
Non absorbable Surgical Silk Suture |
Shandong Haidike Medical Product Co., Ltd. |
Yan Wang |
| K232475 |
08/16/2023 |
Disposable infusion set with needle |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K232409 |
08/10/2023 |
Electromagnetic Stimulation Systems |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K232550 |
08/23/2023 |
Nitrile Examination Gloves, Dual Color Black-Blue |
Shanxi Hongjin Plastic Technology Co., Ltd. |
Zhigang Wu |
| K232353 |
08/07/2023 |
Powder Free Nitrile Examination Gloves (Black) |
Shanxi Hongjin Plastic Technology Co., Ltd. |
Wu Zhigang |
| K232435 |
08/14/2023 |
Rhinolaryngoscope system |
Shenzhen HugeMed Medical Technical Development Co., Ltd. |
Cathy Shi |
| K232529 |
08/21/2023 |
Disposable Double Lumen Endobronchial Tube |
Shenzhen Insighters Medical Technology Co., Ltd. |
Bonnie Fang |
| K232580 |
08/25/2023 |
Disposable Endobronchial Blocker Tube |
Shenzhen Insighters Medical Technology Co., Ltd. |
Bonnie Fang |
| K232575 |
08/25/2023 |
Hair Removal Device, Model(s): R2815-G Pro, R2815-G |
Shenzhen Jianchao Intelligent Technology Co., Ltd. |
Fred Li |
| K232517 |
08/18/2023 |
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) |
Shenzhen Kentro Medical Electronics Co., Ltd. |
Zewu Zhang |
| K232499 |
08/17/2023 |
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) |
Shenzhen Lescolton Electrical Appliance Co., Ltd. |
Chen Zhikui |
| K232460 |
08/15/2023 |
Disposable electrosurgical pencil (MD1000) |
Shenzhen Mecun Medical Supply Co., Ltd. |
Bo Zheng |
| K232587 |
08/25/2023 |
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer |
Shenzhen New Industries Biomedical Engineering Co., Ltd |
Xiaoli Wang |
| K232520 |
08/18/2023 |
Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alp |
Shenzhen Smallsignal Technology Co., Ltd. |
Qingliang Liu |
| K232624 |
08/29/2023 |
CardioPhase« hsCRP |
Siemens Healthcare Diagnostic Products GmbH |
Petra Dissmann |
| K232305 |
08/01/2023 |
AI-Rad Companion Brain MR |
Siemens Medical Solutions U.S.A. |
Kira Morales |
| K232494 |
08/17/2023 |
MAGNETOM Avanto fit; MAGNETOM Skyra fit |
Siemens Medical Solutions USA, Inc. |
Milind Dhamankar |
| K232535 |
08/21/2023 |
MAGNETOM Sola; MAGNETOM Altea |
Siemens Medical Solutions USA, Inc. |
Milind Dhamankar |
| K232322 |
08/03/2023 |
MAGNETOM Terra; MAGNETOM Terra.X |
Siemens Medical Solutions USA, Inc. |
Milind Dhamankar |
| K232482 |
08/16/2023 |
MAGNETOM Viato.Mobile |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K232431 |
08/11/2023 |
syngo.CT Brain Hemorrhage |
Siemens Medical Solutions USA, Inc. |
Monsuru Bello |
| K232617 |
08/28/2023 |
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System |
Siemens Medical Solutions, USA, Inc |
Shilpa Rapaka |
| K232339 |
08/04/2023 |
Augmented Reality Application |
Sira Medical, Inc. |
Rick Beberman |
| K232457 |
08/14/2023 |
Q-FIX ULTRA All-Suture Anchor |
Smith & Nephew |
Catherine Phelan |
| K232373 |
08/08/2023 |
ProgripÖ Self-Gripping Polypropylene Mesh |
Sofradim Production |
Anne Bertron |
| K232549 |
08/23/2023 |
NemoCast |
Software Nemotec S.L. |
Miguel del Moral |
| K232455 |
08/14/2023 |
SofWave System |
Sofwave Medical Ltd. |
Ruthie Amir |
| K232607 |
08/28/2023 |
4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM |
Solco Biomedical Copany India Private Limited |
Darshak Shah |
| K232459 |
08/15/2023 |
Velacur |
Sonic Incytes |
Barry Allen |
| K232418 |
08/11/2023 |
Single Platform SP1 Implant System |
Southern Implants (Pty) Ltd |
Colin Saffy |
| K232614 |
08/28/2023 |
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) |
Sri Trang Gloves (Thailand) Public Company Limited |
Jarinya Jirojkul |
| K232655 |
08/31/2023 |
Bonvadis« |
StemCyte Inc. |
Angel Hsieh |
| K232485 |
08/16/2023 |
AMSCO 600 Steam Sterilizer |
Steris |
Anthony Piotrkowski |
| K232350 |
08/07/2023 |
Stryker Facial iD System |
Stryker Craniomaxillofacial |
Jonathan Schell |
| K232470 |
08/16/2023 |
Polyisoprene Extra Large Condom |
Suretex Limited |
Alison Arnot |
| K232511 |
08/18/2023 |
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) |
Surgical Instrument Service and Savings Inc. |
Stephanie Boyle Mays |
| K232647 |
08/31/2023 |
Microcatheter |
Surmodics. Inc. |
Jodie Christe |
| K232581 |
08/25/2023 |
Medical Disposable Sterile Needle Electrode |
Suzhou Haishen Medical Device Associates Co., Ltd |
Leyi Dai |
| K232295 |
08/01/2023 |
LAA Exclusion System |
Syntheon, LLC |
Toygar Unal |
| K232382 |
08/08/2023 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
Christin Dunn |
| K232380 |
08/08/2023 |
t:slim X2 Insulin Pump with Interoperable Technology |
Tandem Diabetes Care, Inc. |
Christin Dunn |
| K232469 |
08/15/2023 |
Rⁿsch Latex Gold Foley Catheter |
Teleflex Medical, Inc. |
Angela Bouse |
| K232441 |
08/14/2023 |
Unipro (K-UNIPRO-US) |
TensCare Ltd |
Saskia Eldridge-Hinmers |
| K232308 |
08/02/2023 |
Monarch Blood Collection Set |
The Monarch Company |
Jonathan Trawick |
| K232479 |
08/16/2023 |
ART-Plan |
TheraPanacea |
Bhairavi Ajachandra |
| K232640 |
08/25/2023 |
Venowave VW5 |
Thermabright |
Liane Parker |
| K232310 |
08/02/2023 |
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K232412 |
08/10/2023 |
LungQ v3.0.0 |
Thirona BV |
Eva Van Rikxoort |
| K232555 |
08/23/2023 |
Harmony |
Topcon Healthcare Solutions |
Tobias Schwarz |
| K232414 |
08/10/2023 |
Klassic« Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K232387 |
08/09/2023 |
Treace Medical Concepts (TMC) Compression Implant System |
Treace Medical Concepts |
Brittany Grochala |
| K232658 |
08/31/2023 |
T-Top 10 & T-Top T-Top 11 |
Tuttnauer U.S.A Co, Ltd |
Jonathan Lane |
| K232552 |
08/23/2023 |
TuxDeluxe (Size 1 6100B, Size 2 6101B) |
Tuxedo Imaging LLC |
Patrick Williams |
| K232652 |
08/31/2023 |
Anatomical Plating System (various) |
Tyber Medical, LLC. |
Lisa Boyle |
| K232319 |
08/03/2023 |
Black Pearl Nitrile Examination Glove |
UG Global Resources Sdn. Bhd. |
Lee Mei Ling |
| K232498 |
08/17/2023 |
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio |
Ultradent Product, Inc. |
Ruth Gardner |
| K232598 |
08/28/2023 |
Unscented Menstrual Tampon |
Unibeauty (Hubei) Technology Co.,Ltd. |
Lin Fongshun |
| K232317 |
08/03/2023 |
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips |
URIT Medical Electronic Co., Ltd. |
Jiang Jun |
| K232462 |
08/15/2023 |
ThermPix Thermovisual Camera |
USA Therm, Inc. |
Eric Heil |
| K232400 |
08/10/2023 |
VariSeed (v10) |
Varian Medical Systems |
Lynn Allman |
| K232623 |
08/29/2023 |
Universal Endometrial Applicator Set (GM11009840) |
Varian Medical Systems Inc. |
Lynn Allman |
| K232584 |
08/25/2023 |
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter |
Vein 360 LLC |
Suzanne Meyer |
| K232384 |
08/08/2023 |
Videa Dental Assist |
VideaHealth, Inc. |
Adam Foresman |
| K232363 |
08/07/2023 |
Viz HDS, Viz Volume Plus, Viz ICH+ |
Viz.ai, Inc. |
Pooja Shah |
| K232616 |
08/28/2023 |
Volta AF-Xplorer |
Volta Medical |
Paola Milpied |
| K232451 |
08/14/2023 |
Insulia Bolus Companion |
Voluntis SA. |
Kevin Howard |
| K232471 |
08/16/2023 |
Vy SpineÖ VyLamÖ Laminoplasty System |
Vy Spine, LLC |
Jordan Hendrickson |
| K232312 |
08/02/2023 |
GORE« PROPATEN« Vascular Graft |
W. L. Gore & Associates, Inc. |
Sarah Pastrnak |
| K232437 |
08/14/2023 |
Paragon 8F Balloon Guide Catheter |
Wallaby Medical |
Joseph Tang |
| K232525 |
08/21/2023 |
Yoni.Fit Bladder Support |
Watkins-Conti Products Inc. |
Allison L Watkins |
| K232625 |
08/29/2023 |
Steriking« Pouch for Robotic Instruments |
Wipak OY |
Hanna Marttila |
| K232538 |
08/22/2023 |
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL |
WRP Asia Pacific Sdn. Bhd. |
Muhammad Ameer Arief Mohd Mujab |
| K232493 |
08/17/2023 |
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) |
Wuhan Huchuang Union Technology Co., Ltd. |
Yuanyuan Zhan |
| K232519 |
08/18/2023 |
ENDOCOLLECT Specimen Retrieval Bag |
Ximedica |
Corie Vazquez |
| K232543 |
08/22/2023 |
MSC SFM |
Yocon Biology Technology Company |
Haifeng Li |
| K232505 |
08/18/2023 |
Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter |
Zhejiang CuraWay Medical Technology Co., Ltd. |
Ruiran Song |
| K232442 |
08/14/2023 |
Disposable Endoscope Injection Needles |
Zhejiang Soudon Medical Technology Co.,Ltd |
Junshi Wang |
| K232450 |
08/14/2023 |
Disposable Hemostatic Clips |
Zhejiang Soudon Medical Technology Co.,Ltd |
Junshi Wang |
| K232476 |
08/16/2023 |
Disposable Sphincterotome |
Zhejiang Soudon Medical Technology Co.,Ltd |
Wang Junshi |
| K232473 |
08/16/2023 |
Infrared Thermometer: Model YJ600 |
Zhuhai Yueja Medical Device Technology Co.,Ltd. |
Feng Yan |
