FDA 510(k) Decisions During September, 2023  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K230847 09/29/2023 Chemotherapy Gloves 3A Glove Sdn. Bhd. Kumar Durarajen
K233257 09/29/2023 3MÖ ClarityÖAligners with Quick Attachments 3M Company, Unitek Orthodontic Products Hillary Peetsch
K231739 09/25/2023 Cervical Spine Truss System (CSTS) 4Web Medical, Inc. Lewis Harrison
K230966 09/19/2023 angiOCCLUDE Ligating Clips A2 Medical Systems, LLC Robert Hall
K214117 09/27/2023 AfinionÖ HbA1c, AfinionÖ 2 and Alere AfinionÖ AS100 Analyzer Abbott Diagnostics Technologies AS Danial Kirmani
K232669 09/29/2023 TBI Abbott Laboratories Lisa Kelly
K232690 09/29/2023 AmuletÖ Steerable Delivery Sheath Abbott Medical Dan Gapp
K232386 09/08/2023 ILUMIENÖ OPTISÖ System, OPTISÖ Integrated System, OPTISÖ Mobile System, with AptiVueÖ Imaging Software version E.6 Abbott Medical Derek Pike
K223755 09/11/2023 i-STAT G cartridge with the i-STAT 1 System Abbott Point of Care Inc. Mojgan Soleimani
K223857 09/15/2023 i-STAT G3+ cartridge with the i-STAT 1 System ABBOTT POINT OF CARE, INC Jacquelyn Gesumaria
K230980 09/22/2023 MicroMatrix« Flex ACell, Inc. Simone Oliver
K232592 09/20/2023 CITRELOCK« DUO Acuitive Technologies, Inc. Matthew Poggie
DEN230021 09/13/2023 ensoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical Erik Kulstad
K232701 09/29/2023 Guardenia (GAR-1) Advanced Surgical Concepts Edward Hyland
K223659 09/22/2023 Jazz AI Medical AG Christian Federau
K223179 09/20/2023 Cholestech LDX Ö System Alere San Diego, Inc. Nathifa Bradshaw
K231146 09/08/2023 AliTight Alic Iotech, LLC Like Zeng
K230649 09/07/2023 Arm Blood Pressure Monitor Alicn Medical Shenzhen, Inc Fang Meisong
K232233 09/26/2023 Invisalign System with Mandibular Advancement Featuring Occlusal Blocks Align Technology, Inc. John Ray
K221570 09/29/2023 Antibacterial bandage Allmed Medical Products Co., Ltd. Vince Tian
K223621 09/08/2023 DeepXray Alpha Intelligence Manifolds, Inc. Qingzong Tseng
K232413 09/08/2023 Fusion Robotic Navigation System Alphatec Spine, Inc. Sarah Braun
K232097 09/25/2023 IdentiTi ALIF Interbody Systems Alphatec Spine, Inc. Andrew Zhang
K232275 09/27/2023 Invictus« Spinal Fixation System Alphatec Spine, Inc. Cynthia Dorne
K230925 09/27/2023 Disposable Injection Needle AF series Alton (Shanghai) Medical Instruments Co. Ltd Vivian Li
K232582 09/20/2023 Ambu« aScopeÖ 5 Broncho 4.2/2.2 Sampler Set Ambu A/S Eva Lind Rasmussen
K230332 09/15/2023 Ambu« aScopeÖ Colon; Ambu« aBoxÖ 2 Ambu A/S Mette Andersen
K230043 09/20/2023 Insulin Pen Needle Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Bingyi Xiang
K231767 09/22/2023 Annalise Enterprise CTB Triage Trauma Annalise-AI Pty Ltd Haylee Bosshard
K231384 09/22/2023 Annalise Enterprise CTB Triage Trauma Annalise-AI Pty Ltd. Haylee Bosshard
K232699 09/28/2023 Low Ejection Fraction AI-ECG Algorithm Anumana, Inc. Suzanne Goodman
K223901 09/01/2023 ApneaRX Pro Apnea Sciences Coporation James Fallon
K232544 09/18/2023 Apollo ESG NXT System, Apollo REVISE NXT System Apollo Endosurgery Inc. James Shene
K232443 09/07/2023 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit Argon Medical Devices, Inc. Ana Jimenez-Hughes
K230824 09/06/2023 IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) Art Optical Contact Lens, Inc. Jill Anastor
K231353 09/14/2023 AccuCTP Pro ArteryFlow Technology Co., Ltd. Jianping Xiang
K230513 09/26/2023 Arthrex Univers Apex OptiFit Humeral Stem Arthrex Inc Tiffany Mentzel
K232340 09/01/2023 Arthrex 2.4mm Knotless Hip SutureTak« Suture Anchor Arthrex Inc. Alex Underberg
K231649 09/29/2023 Intraosseous Fusion Device System Auxano Medical LLC Jennifer Hazou
K231242 09/15/2023 Perifix FX Catheter; Contiplex FX Catheter B. Braun Medical Inc. Tracy Larish
K222251 09/18/2023 B╖R╖A╖H╖M╖S CgA II KRYPTOR, B╖R╖A╖H╖M╖S CgA II KRYPTOR CAL, B╖R╖A╖H╖M╖S CgA II KRYPTOR QC B.R.A.H.M.S GmbH part of Thermo Fisher Anne Kummerow
K231827 09/15/2023 BTI Dental Implant System UnicCa« û Aesthetic Post Abutments B.T.I. Biotechnology Institute, S.L. JosΘ Ram≤n Rivero
K231092 09/22/2023 T-SHAPE 2 B&M S.R.L. Marketing Nel Benessere Brando Baldan
K230987 09/14/2023 FlowStar Analog Mixer Flowmeter Baldus Sedation GmbH & Co. KG Lisa Baldus
K230609 09/13/2023 NG Delivery Catheter Balt USA, LLC Catherine Chiou
K231283 09/11/2023 SiteRiteÖ 9 Ultrasound System Bard Access Systems, Inc. (C.R. Bard, Inc.) Fabio De Pasquale
K232467 09/14/2023 CleanCart A, CleanCart C, AK 98 Hemodialysis Machine Baxter Healthcare Corporation Kristen Bozzelli
K223921 09/22/2023 Access CEA Beckman Coulter, Inc Abhi Kannan
K231832 09/18/2023 Access Myoglobin Beckman Coulter, Inc Kate Oelberg
K220972 09/15/2023 Access Thyroglobulin Beckman Coulter, Inc Abhi Kannan
K213517 09/26/2023 Access Thyroglobulin Antibody II Beckman Coulter, Inc. Abhi Kannan
K231239 09/22/2023 NexivaÖ Closed IV Catheter System with NearPortÖ IV Access Becton Dickinson Infusion Therapy Systems Inc. Paul Holman
K230865 09/28/2023 PIVOÖ Pro Needle-free Blood Collection Device Becton Dickinson Infusion Therapy Systems, Inc. Amy Moore
K230024 09/06/2023 HI-EMT MAGSHAPE Beijing Sano Laser S&T Development Co., Ltd Hongbo Zhang
K223919 09/23/2023 B.Light Clear Evo and B.Light Restore Evo Bemer INT. AG Sandra Schwarzenberger
K231628 09/29/2023 BeShape OneÖ Device BeShape Technologies Ltd. Amit Goren
K232224 09/22/2023 iLet« Dosing Decision Software Beta Bionics, Inc. Liz Cooper
K213987 09/20/2023 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls Biokit, S.A. Angels Roma
K231207 09/07/2023 CARTOÖ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) Biosense Webster, Inc. Caleb Lau
K230884 09/26/2023 AVVIGO'+ Multi-Modality Guidance System Boston Scientific Corporation Kevin Catalano
K232651 09/29/2023 BLAZERÖ Dx-20 Bidirectional Steerable Diagnostic Catheter Boston Scientific Corporation Laura Wotta
K230735 09/13/2023 Ultimate rTMS; Yingchi rTMS Brain Ultimate, Inc. Frank Ge
K223864 09/09/2023 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial Brainlab AG Esther Moreno Garcia
K231837 09/28/2023 Brainomix 360 Triage LVO Brainomix Limited Thais Sala
K232172 09/18/2023 BTL-785BNF Handpiece BTL Industries Inc. David Chmel
K230467 09/21/2023 BTL-899F BTL Industries Inc. David Chmel
K221601 09/01/2023 MS-39 C.S.O. S.r.l. Gilda Mura
K231281 09/19/2023 Aquilion Serve (TSX-307A/1) V1.3 Canon Medical Systems Corporation Paul Biggins
K231748 09/12/2023 Cartesion Prime (PCD-1000A/3) V10.15 Canon Medical Systems Corporation Paul Biggins
K232526 09/12/2023 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 Canon Medical Systems Corporation Paul Biggins
K231538 09/27/2023 FreedomFlow Orbital Circumferential Atherectomy System Cardio Flow, Inc. Michael J. Kallok
K221640 09/13/2023 AlloMap Heart Molecular Expression Testing CareDx, Inc. Camilla Lu
K231888 09/25/2023 BD TexiumÖ Needle-Free Syringe Carefusion Breanna Casados
K232159 09/21/2023 QEVO System Carl Zeiss Meditec AG Eva Jankovics
K230350 09/22/2023 VISULAS yag Carl Zeiss Meditec Inc Tanesha Bland
K232583 09/20/2023 Catalyst R1 Reverse Shoulder System Catalyst OrthoScience, Inc. Dale Davison
K222638 09/27/2023 Xpert« Xpress GBS, GeneXpert« Dx System, GeneXpert« Infinity Systems Cepheid Suzette Chance
K230881 09/11/2023 Change Healthcare Cardiology HemodynamicsÖ Change Healthcare Israel Ltd. Alona Golik
K232068 09/01/2023 HyperLight Portable X-ray Unit Changzhou Sifary Medical Technology Co., Ltd. Tao Huan
K223869 09/14/2023 ChoiceSpine Blackhawk Ti Cervical Spacer System ChoiceSpine, LLC Kim Finch
K232102 09/15/2023 ClearPoint Array System (Version 1.2) ClearPoint Neuro, Inc. Brennan Sullivan
K231335 09/08/2023 Cleerly ISCHEMIA Cleerly, Inc Candice Bautista-Biddle
K231891 09/25/2023 Virtue Male Sling System with Alexis Wound Retractor Convenience Kit Coloplast Jennifer Mrkvicka
K231576 09/14/2023 cNeuro cPET Combinostics Oy Thurfjell Lennart
K232426 09/08/2023 Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts Conformis Inc Mary Kruitwagen
K230239 09/20/2023 AirSeal iFS System; AirSeal dV Solution CONMED Corporation Tina Mornak
K231047 09/01/2023 UniSyn Molecular Imaging (6-3-1) Convergent Imaging Solutions Mathew Thomas
K213273 09/01/2023 Brain Anesthesia Response Monitor (Bar Monitor) Cortical Dynamics Ltd Louis Delacretaz
K232686 09/08/2023 CorVista« System CorVista Health, Inc. Gabrielle Zaeska
K231240 09/08/2023 MaxTackÖ Motorized Fixation Device Covidien Megha Patel
K230591 09/29/2023 TriLEAP Plating System CrossRoads Extremity Systems Keith Knapp
K232556 09/20/2023 DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System Depuy Ireland UC Susan Mullane
K232178 09/19/2023 GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) DRGEM Corporation Park Sunghee
K232487 09/14/2023 Provecta 3D Prime and Provecta 3D Prime Ceph Durr Dental SE Oliver Lange
K212769 09/29/2023 DYNEX SmartPLEX MMRV IgG Assay Kit Dynex Technologies Inc. Jeff Fisher
K232336 09/26/2023 ES Series V2 E-Scopics Claude Cohen Bacrie
K230184 09/25/2023 Holter ECG and ABP System Edan Instruments, Inc. Lavender Wang
K231248 09/21/2023 Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform Edwards Lifesciencess LLC Anne Lo
K231971 09/26/2023 DEKA PHYSIQ 360 El.En. S.p.A Paolo Peruzzi
K232334 09/01/2023 DEKA SIMON El.En. S.p.A. Paolo Peruzzi
K230317 09/01/2023 Elos Accurate Hybrid Base Elos Medtech Pinol A/S Lise Terkelsen
K232596 09/27/2023 EndoGI S-Path Biliary Stent System EndoGI Medical, Ltd. Omri Naveh
K213767 09/12/2023 Endure ETCO2/02 Nasal Cannula Endure Industries Inc Manoj Kumar
K232014 09/01/2023 CONDUITÖ ATP Inserters Enztec Limited James Sheat
K223674 09/01/2023 eZSUREÖ Empty Fluid Container (models 426030, 426040, 426110) Epic Medical Pte Ltd Freddie Lee
K231928 09/25/2023 EFAI RTSUITE CT HCAP-Segmentation System Ever Fortune.AI Co., Ltd. Joseph Chang
K232002 09/11/2023 Vantage« Total Ankle System Exactech Inc. Liz Howell
K223933 09/25/2023 Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws Exactech, Inc Valdimir Talley
K223833 09/14/2023 Exactech« Equinoxe« Reverse Humeral Liners and Humeral Adapter Trays Exactech, Inc Liz Howell
K223622 09/01/2023 FaceHeart Vitals Software Development Kit (FH vitals SDK) FaceHeart Corp. Morris Chung
K231730 09/22/2023 FemaSeed Intratubal Insemination Femasys Inc. Christine Thomas
K231141 09/08/2023 STarFix Designer Software C0265 FHC, Inc. Kelly Moeykens
K223684 09/05/2023 F&P 820 Humidification System Fisher & Paykel Healthcare Ltd Reena Daken
K231446 09/22/2023 Single-Use Latex Sterile Surgical Gloves (SG100) Fitone Latex Products Co., Ltd. Guangdong Christine Ou
K231977 09/25/2023 PEACH 2, PEACH 2 Duo, PEACH 2 go Foreo Inc. Evan Feldstein
K220179 09/22/2023 High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors Foshan COXO Medical Instrument Co., Ltd. Zheng Yongjian
K231717 09/06/2023 IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 Foshan Jindi Electric Appliance Co.,Ltd Zhaozhi Li
K221274 09/29/2023 StarFormer, TightWave Fotona d.o.o. Tina Bartolic
K223827 09/08/2023 FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 FUJIFILM Corporation Randy Vader
K232314 09/01/2023 Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) Fujifilm Healthcare Americas Corporation Chaitrali Kulkarni
K230752 09/15/2023 Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) Fujifilm Healthcare Americas Corporation Kotei Aoki
K231892 09/12/2023 Definium Pace Select GE Hualun Medical Systems Co. Ltd. Miny Liu
K232569 09/21/2023 CAREMIBRAIN General Equipment for Medical Imaging, S.A. Maria Climent
K232158 09/13/2023 GenX-CR Genoray Co., Ltd. Inyoung Kim
K223214 09/21/2023 Powder-Free Nitrile Examination Gloves Global Protection Corp. Christina Cataldo
K231342 09/20/2023 Insufflator (OPTO-IFL1000) Guangdong OptoMedic Technologies, Inc. Weijuan Guo
K231363 09/27/2023 Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) Hantech Medical Device Co., Ltd. Arnold Yang
K222921 09/08/2023 Minuteful-kidney test Healthy.io Ltd. Ron Zohar
K230237 09/14/2023 Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. Chen Yang
K232189 09/14/2023 OrionXR Hoth Intelligence Inc. Jonathan Cohen
K222988 09/01/2023 neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical HT Medical d.b.a. Xenix Medical Ryan Phillips
K221052 09/25/2023 Self-Fitting hearing aids Huizhou Jinghao Medical Technology Co., Ltd. Yuanxia Mao
K230102 09/21/2023 Smart double sides wearable breast pump, Electric bilateral breast pump Huizhou LVB Maternal And Infant Supplies Co,Ltd. Dongan Zhang
K230743 09/05/2023 ICHOR 14F Embolectomy System ICHOR Angela Mallery
K231791 09/15/2023 PENTO Nd:YAG and Alexandrite laser system Ilooda Co,.Ltd. Mason Moon
K223811 09/13/2023 Lung-CAD Imagen Technologies, Inc Rebecca Jones, PhD
K221817 09/22/2023 ALFIS Vitamin D, ALFIS-3 Analyzer Immunostics Inc. Young Mi Kim
K231688 09/16/2023 ImPACT Version 4 ImPACT Applications, Inc. Michael Zagorski
K231108 09/27/2023 Talon Transseptal Sheath Inari Medical, Inc. Ellen Nguyen
K231973 09/29/2023 PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove Ineo Tech Sdn Bhd Pierre Hoerner
K232260 09/27/2023 Thinline Sheath Introducer Inneuroco Inc. Marc Litzenberg
K231819 09/05/2023 Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw Innovate Orthopaedics Limited Mike Bilson
K231663 09/18/2023 The AVEOtsd (Tongue Stabilizing Device) Mouthpiece Innovative Health Technologies (NZ), Ltd Chapman Philip
K220458 09/29/2023 UltraFlo-R Push Button Blood Collection Set Innovative Medical Technologies, Inc. Brad Brown
K213403 09/29/2023 Aptiva CTD Essential Reagent Inova Diagnostics, Inc. Andrea Seaman
K230108 09/14/2023 Straumann« BLC and TLC Implants Institut Straumann AG Corinne Arimatea
K221359 09/29/2023 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-▀2 Glycoprotein-I IgM Instrumentation Laboratory Co. Nikita Malladi
K231147 09/14/2023 HammerdesisÖ Interphalangeal Fusion System Intelivation David Posillico
K230623 09/01/2023 KITE Distal Fibula Kit Intrauma S.p.A Piero Costa
DEN210011 09/29/2023 Invitae Common Hereditary Cancers Panel Invitae Corporation Elaine Cull
K230517 09/11/2023 Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) Jarmon Medical, LLC (DBA Legends Orthopedics) Jeremy Jarmon
K221743 09/07/2023 Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes Jiangsu Bonss Medical Technology Co., Ltd. Feir Zeng
K213413 09/01/2023 Hemostatic Dressing Jiangsu NewValue Medical Products Co., Ltd. Lu Wang
K230598 09/12/2023 Stone Extraction Baskets Jiangsu Vedkang Medical Science and TechnologyCo.,Ltd Qian Wen
K230974 09/15/2023 NIDOÖ Pedicle Screw System Kalitec Medical Keith Cannon
K223885 09/14/2023 HOPKINS Telescopes Karl Storz Endoscopy America, Inc. Jordan Lydia Verla
K230535 09/08/2023 KARL STORZ Urological Laser Accessories Karl Storz SE & CO. KG Alita McElroy
K200583 09/05/2023 Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL Ki Mobility LLC Mark Murphy
K201869 09/05/2023 Ki Power Tilt System Ki Mobility LLC Mark Murphy
K230644 09/07/2023 Signum opaque F Kulzer, LLC David Vincent
K231766 09/12/2023 Skyway Anterior Cervical Plate System Kyocera Medical Technologies, Inc. (KMTI) Joey Thompson
K232571 09/22/2023 CATHTONGÖ II PICC Catheter L&Z US, Inc. James Li
K232594 09/22/2023 CATHTONGÖ II PICC Catheter L&Z US, Inc. James Li
DEN220026 09/26/2023 VasQ Laminate Medical Technologies Ltd. Orit Yarden
K232605 09/28/2023 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
K231687 09/07/2023 Gradual Dental Zirconia Blank Liaoning UPCERA CO., Ltd Li Luo
K232827 09/14/2023 LightForce Orthodontic System LightForce Orthodontics Jeffrey Roberts
K231957 09/29/2023 SafeBreak« Vascular Lineus Medical Vance Clement
K232274 09/28/2023 IPL hair removal device Lumenessa Corp Peter Kim
K232389 09/07/2023 Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue Masimo Corporation Kertana Shankar
K231112 09/12/2023 Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV Giulia Girola
K230011 09/20/2023 Mpact Extension Medacta International S .A. Stefano Baj
K223421 09/20/2023 MedCAD AccuPlan Orthopedics System MedCAD Brian Buss
K230398 09/26/2023 MedCAD« AccuPlate« 3DTi Patient-Specific Plating System MedCAD Brian Buss
K220396 09/26/2023 EasyStat 300 Medica corporation Photios Makris
K231901 09/28/2023 Hakon, Hakon Smart Medical San Ind·stria de Equipamentos MΘdicos Ltda Francis Laion de Padua
K230918 09/01/2023 MasterX 800 Series Medicatech USA George Makar
K231106 09/19/2023 Accuject Refra Injector AR2900 Medicel AG Erik Braziulis
K223835 09/18/2023 MA-40, MA-112 Medify Air LLC Pragati Anand
K231527 09/29/2023 TriALTIS Navigation Enabled Instruments Medos International S└RL Nicole Aeschbacher
K231479 09/22/2023 TriALTIS Spine System Medos International SARL Megan Smith
K223788 09/15/2023 The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter MedSource International LLC Amanda Salentine
K231011 09/12/2023 Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse Meridian AG Eric Odenheimer
K232609 09/27/2023 Micro AceÖ Advanced Micro Access System Merit Medical Systems, Inc. Garry Courtney
K232299 09/29/2023 CeraPutty Meta Biomed Co., Ltd. Suk Song Oh
K230127 09/06/2023 Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible Micro-Tech (Nanjing) Co., Ltd. Sally He
K231007 09/27/2023 CEDIA Heroin Metabolite (6-AM) Assay Microgenics Corporation Amrit Takhar
K230563 09/27/2023 EVOLUTION« Hinge Knee System MicroPort Orthopedics Inc. Ryan Ross
K230775 09/14/2023 SOFIA EX Intracranial Support Catheter MicroVention, Inc. Miranda Beach
K223085 09/29/2023 Miris Human Milk Analyzer (HMA) Miris AB Elin Hallen
K232154 09/11/2023 MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation MiRus, LLC Jordan Bauman
K222948 09/19/2023 Q Distal Access Catheter MIVI Neuroscience, Inc Srija Reddy Bandari
K231884 09/01/2023 TRIOCLEAR System Modern Dental Laboratory (DG) Co., Ltd. Robin Liu
K232508 09/15/2023 Barrier EasyWarm Active Self-Warming Blanket Molnlycke Health Care US, LLC Megan Bevill
K232146 09/14/2023 Anovo Pedestal Momentis Surgical Ltd. Maya Leib Shlomo
K230767 09/21/2023 Pelvic Floor Muscle Stimulator Nanjing Vishee Medical Technology Co., Ltd. Qiu Kai
K223575 09/06/2023 Phoenix ICON, Phoenix ICON GO NeoLight, LLC Amy Oakes
K232558 09/22/2023 UroLift 2 ATC Advanced Tissue Control System NeoTract, Inc. Kelsey Krische
K230067 09/22/2023 Para-Fix External Fixation System New Paradigm Biomedical John Wixted
K232530 09/18/2023 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System Nexus Spine, LLC Jared Crocker
K232121 09/15/2023 Power wheelchair (Model:BC-EA8000) Ningbo Baichen Medical Devices Co., Ltd. Wu Xiao Long
K221900 09/29/2023 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Sharvari Nayak
K230372 09/08/2023 VitreJect Syringe OcuJect, LLC Leonid Lerner
K230959 09/14/2023 VitreJect« Needle; OcuSafe« Needle OcuJect, LLC Leonid Lerner
K231284 09/08/2023 OnPoint Augmented Reality Spine System OnPoint Surgical, Inc. Amy ODonnell
K221197 09/05/2023 VITROS Immunodiagnostic Products Intact PTH II Reagent Pack Ortho Clinical Diagnostics Declan Hynes
K231270 09/01/2023 Montage Flowable Settable, Resorbable Bone Paste Orthocon, Inc. Aniq Darr
K230252 09/26/2023 OFIX MIS App Orthofix US LLC Shant Aghyarian
K232315 09/15/2023 Catalyst Bone Void Filler OssDsign AB Jonas Aberg
K230750 09/13/2023 OSSIOfiber« Cannulated Trimmable Fixation Nail Ossio Ltd. Taly Lindner
K222778 09/23/2023 Osstem Implant System Osstem Implant CO., LTD. Seungju Kang
K231079 09/14/2023 LW Retraction Cap Ossvis Co., Ltd. Young Jae Kim
K231235 09/15/2023 LW UCLA Abutment Ossvis Co., Ltd. Young Jae Kim
K230226 09/21/2023 Integrity-SI« Fusion System OsteoCentric Technologies Todd Evans
K231702 09/29/2023 WiScope« Digital Cystoscope System, WiScope« Single-Use Digital Flexible Cystoscope, WiScope« Medical Tablet OTU Medical Inc. Geping Liu
K231678 09/21/2023 Overjet Periapical Radiolucency Assist Overjet, Inc Deepthi Paknikar
K232513 09/18/2023 X-Twist Biocomposite Suture Anchor Parcus Medical Calen Souther
K230483 09/16/2023 Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) Passy-Muir, Inc. Donna Malter
K231802 09/19/2023 Millipede 088 Access Catheter Perfuze Ltd. Anne-Marie Gannon
K232657 09/01/2023 InnerView LC Perimetrics, Inc Alicia Mszyca
K232021 09/01/2023 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T Philips Healthcare (Suzhou) Co., Ltd. Li Sherry
K231401 09/21/2023 Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva Poly Medicure Limited Ramdas Sharma
K221860 09/15/2023 PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe Poonglim Pharmatech Inc. Hee Min Cho
K230778 09/25/2023 EndoCore Praxis Medical, LLC John Fisher
K222831 09/13/2023 CRYOcheck Factor VIII Deficient Plasma with VWF Precision BioLogic Inc. Karen Black
K220735 09/15/2023 Avologi Gel Primer (Model: Av25) Premier North America Inc. Ellis Tamari
K232166 09/08/2023 PreXion3D Expedition PreXion Corporation Kenji Tanaka
K223496 09/26/2023 Inclusive« Titanium Abutments compatible with: Straumann« Bone Level SC, BioHorizons« Tapered Internal, MIS« C1 Implant Systems Prismatik Dentalcraft, Inc. So Hyun Park
DEN220023 09/29/2023 Procise ADL ProciseDx Inc. Kurt Bray
DEN210056 09/29/2023 Procise IFX ProciseDx Inc. Kurtis R. Bray
K230692 09/20/2023 TULSA-PRO System Profound Medical Inc. Nicole Baker
K232361 09/05/2023 Promaxo MRI System II Promaxo, Inc. Veronica Sanz
K231792 09/28/2023 VeriSafe Safety sterile syringes Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang
K231484 09/14/2023 PureWay 1.4 Quart Sharps Collector PureWay Compliance Inc. Jeffery Miglicco
K223873 09/29/2023 Boppli Infant Blood Pressure Monitor PyrAmes Inc. Xina Quan
K232255 09/27/2023 EZSensor XHD Qpix Solutions Inc. Seungman Yun
K231149 09/22/2023 qXR-CTR Qure.ai Technologies Srinidhi Ragunathan
K222938 09/12/2023 Ablation-fit R.A.W. Srl Chiara Ferrari
K230890 09/08/2023 ISE Electrodes Randox Laboratories Ltd. Karena Shaw
K231622 09/29/2023 REGER Nebulizer Irrigation Cannula REGER Medizintechnik, GmbH Christopher Kohn
K222610 09/15/2023 Elecsys Anti-Tg Roche Diagnostics Phil Williams
K221890 09/30/2023 Elecsys Tg II Roche Diagnostics Edie Eads
K231385 09/20/2023 Rology Teleradiology Platform (v.1.22.1103) Rology Inc. Amr Abodraiaa
K230193 09/21/2023 Servator P Plus SALF Solution S.A.L.F. spa Carmelo Gagliano
K232650 09/29/2023 KHEIRON« Spinal Fixation System, including patient specific K-ROD S.M.A.I.O Jean-Charles Roussouly
K223354 09/21/2023 EGIS Biliary Single Bare Stent S&G Biotech Inc. Sung-Kwon Kang
DEN230006 09/06/2023 esolution S4 Medical Corp William Fuller
K221508 09/29/2023 AnemoCheck Home Sanguina, Inc. Cathryn Cambria
K223913 09/20/2023 Socrates Aspiration System Scientia Vascular Inc Thomas Lippert
K231030 09/14/2023 Cove Putty, OsteoCove Putty SeaSpine Orthopedics Corporation Cindy Toyama
K232668 09/27/2023 Cove Strip, OsteoCove Strip SeaSpine Orthopedics Corporation Cindy Toyama
K230746 09/14/2023 Non absorbable Surgical Polypropylene Suture Shandong Haidike Medical Products Co.,Ltd. Yan Wang
K231367 09/18/2023 Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) Shenzhen Finicare Co., Ltd. Chao Li
K232183 09/22/2023 IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 Shenzhen Koli Technology Co.,Ltd Qizhen Fu
K230362 09/11/2023 Planar LED mate Shenzhen Leaflife Technology Co., Ltd Cheng Qiang
K231800 09/07/2023 IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 Shenzhen Qianyu Technology Co., Ltd. Guoyang Li
K230066 09/15/2023 Carnation series Diagnostic Ultrasound System Shenzhen Wisonic Medical Technology Co., Ltd. Jiang Xiaosan
K232124 09/14/2023 IPL Hair Removal, Model: W-1095, W-1098 Shenzhen Wochuan Electronic Co., Ltd Rebecca Jiang
K231894 09/20/2023 LED Spectrum therapy instrument Shenzhenshi Sincoheren S&T Development Co.,Ltd. Zhongzhou Li
K233161 09/28/2023 BeautiLink SA Shofu Dental Corporation Mauro Malzyner
K213510 09/08/2023 IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA Siemens Healthcare Diagnostics Products Ltd Stefani Vinkemeier
K220265 09/24/2023 ADVIA Centaur« NT-proBNPII (PBNPII) Siemens Healthcare Diagnostics, Inc. Asha Gartland
K223812 09/15/2023 Sensis Vibe (VD15) Siemens Medical Solutions USA Inc. Patricia D Jones
K232482 09/06/2023 MAGNETOM Viato.Mobile Siemens Medical Solutions USA, Inc. Alina Goodman
K232617 09/26/2023 ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System Siemens Medical Solutions, USA, Inc Shilpa Rapaka
K221309 09/19/2023 AI100 with Shonit SigTuple Technologies Pvt. Ltd. Tathagato Rai Dastidar
K232978 09/22/2023 DX. Bond V Dental Bonding Adhesive Sino-Dentex Co., Ltd. Pengtao Yan
K231188 09/28/2023 ALIGN Radial Head System Skeletal Dynamics Inc Alexandra Rodriguez Rojas
K230825 09/25/2023 Smileyscope System (Therapy Mode) Smileyscope Holding Inc. Paul Leong
K232457 09/08/2023 Q-FIX ULTRA All-Suture Anchor Smith & Nephew Catherine Phelan
K231710 09/01/2023 OW100S Softwave./TRT LLC John Warlick
K232459 09/12/2023 Velacur Sonic Incytes Barry Allen
K230310 09/08/2023 STAT Medical Device Lancing System STAT Medical Devices Hemel Mariano
K232485 09/13/2023 AMSCO 600 Steam Sterilizer Steris Anthony Piotrkowski
K231746 09/11/2023 VERIFY Spore Test Strip for S40 Sterilant Concentrate Steris Corporation Gregory Land
K231854 09/20/2023 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM Stryker April Malmborg
K230045 09/29/2023 HipCheck Stryker Corp. Lucas Dun
K222823 09/07/2023 AeroDVx Arm System Sun Scientific Inc Allan Alward
K230857 09/25/2023 TiLink-P SI Joint Fusion System Surgentec, LLC Andrew Shoup
K231828 09/07/2023 PounceÖ Sheath Surmodics, Inc. Peter Bather
K232647 09/29/2023 Microcatheter Surmodics. Inc. Jodie Christe
K221869 09/05/2023 BCR-ABL1 (p210) % IS Kit (Digital PCR Method) Suzhou Sniper Medical Technologies Co., Ltd Peng Zhang
K230167 09/14/2023 BACK 4 SWIMS America Corp Matthieu Commeau
K231643 09/08/2023 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Syntex Healthcare Products Co., Ltd. Qiao Zhiqiang
K231336 09/15/2023 T2 Biothreat Panel T2 Biosystems, Inc. Rachel Gilbert
K230187 09/29/2023 Terran NM-101 Terran Biosciences, Inc. Sam Clark
K232414 09/08/2023 Klassic« Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post Total Joint Othopedics, Inc. Chris Weaber
K230526 09/14/2023 TEA Device Transtimulation Research, Inc. Jieyun Yin
K230946 09/15/2023 Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L Trax Surgical Steven Tallarida
K230805 09/01/2023 TriMed Clavicle Fixation System TriMed, Inc. David Medoff
K230049 09/07/2023 SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING TTK Healthcare Limited Daniel J S
K223848 09/08/2023 IntrisoundÖ Tuned Lumen« 155 Hearing Aids Tuned Ltd Orit lanco
K232462 09/14/2023 ThermPix Thermovisual Camera USA Therm, Inc. Eric Heil
K232400 09/08/2023 VariSeed (v10) Varian Medical Systems Lynn Allman
K231317 09/12/2023 TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc. Peter J. Coronado
K232192 09/11/2023 Venus Versa PRO System Venus Concept Inc. William H. McGrail
K231504 09/11/2023 TITANEXÖ MICROBEAM Screw System, TITANEXÖ ARTEMIS Screw System Vilex LLC Brock Johnson
K232616 09/27/2023 Volta AF-Xplorer Volta Medical Paola Milpied
K232167 09/27/2023 VySpanÖ PCT System Vy Spine, LLC Jordan Hendrickson
K231076 09/27/2023 VariLift«-C Interbody Fusion System Wenzel Spine, Inc. William Wilson
K231542 09/07/2023 Digital Blood Pressure Monitor WBP Series Weony (Shenzhen) Technology Co., Ltd. Autumn Liu
K231727 09/08/2023 Sterile Auto-Disable Syringes with/without Needle for Single Use Wepon Medical Technology Co., Ltd. Di Zhao
K231720 09/08/2023 Sterile Hypodermic Needles for Single Use Wepon Medical Technology Co., Ltd. Di Zhao
K231723 09/08/2023 Sterile Safety Hypodermic Needles for Single Use Wepon Medical Technology Co., Ltd. Di Zhao
K231729 09/08/2023 Sterile syringes for single use with/without needle Wepon Medical Technology CO., Ltd. Di Zhao
K231999 09/07/2023 Steriking« LT-Blueline Pouches with Tyvek« Wipak OY Hanna Marttila
K231996 09/07/2023 Steriking« LT-Blueline Pouches with Tyvek« Wipak OY Hanna Marttila
DEN230007 09/01/2023 LightStrike+ (MXSUV1-SL and MXSUV1-FT) Xenex Disinfection Services, Inc. Juan L. Gonzalez
K232193 09/22/2023 Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) Yurob Rehabilitation Medical Co.,Ltd. Pan Daoping
K230661 09/08/2023 Zeta Cranial Navigation System Zeta Surgical Jose Amich
K231471 09/08/2023 Air/Water Bottle Tubing, CO2 Source Tubing Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long
K232199 09/15/2023 Bariatric Heavy Duty Wheelchair (YJ-010B 20ÆÆDS; YJ-010B 20ÆÆDE; YJ-010B 20ÆÆDFS; YJ-010B 20ÆÆDFE;YJ-010B 20ÆÆADS; YJ-010B 20ÆÆADE; YJ-010B 20ÆÆADFS; YJ-010B 20ÆÆADFE; YJ-010B 22ÆÆDS; YJ-010B 22ÆÆDE; YJ-010B 22ÆÆDFS;YJ-010B 22ÆÆDFE; YJ-010B 22ÆÆADS;YJ-010 Zhenjiang Assure Medical Equipment Co., Ltd. Ying Mei
K232198 09/15/2023 Reclining wheelchair (YJ-011S 16öD, YJ-011S 16öDF, YJ-011S 18öD, YJ-011S 18öDF, YJ-011S 20öD, YJ-011S 20öDF) Zhenjiang Assure Medical Equipment Co., Ltd. Ying Mei
K232691 09/05/2023 Polibond Zirkonzahn Srl Sorana Siclovan
K231013 09/28/2023 DNA/RNA Shield SafeCollect Saliva Collection kit Zymo Research Julie Ogi


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