FDA 510(k) clearances — page 90

176,479 clearances on record, most recent first.

Clearances — page 90

8,901–9,000 of 176,479

K232860 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.·Product code EOQ·2024-01-18
K233077 — FlashHeal 2 (FlashHeal 2.0)Inwound Aps·Product code GEX·2024-01-18
K233190 — ENFit AdaptorJiangsu Caina Medical Co.,Ltd·Product code PIO·2024-01-18
K233213 — NxStage PureFlow SolutionNxstage Medical, Inc.·Product code KPO·2024-01-18
K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc.·Product code NQD·2024-01-18
K233447 — CeQur Simplicity On-Demand Insulin Delivery SystemCequr SA·Product code OPP·2024-01-18
K233451 — Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.·Product code GCJ·2024-01-18
K233507 — EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.·Product code MBH·2024-01-18
K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT) +4 moreWilliam Cook Europe Aps·Product code DTK·2024-01-18
K233744 — Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.·Product code MAX·2024-01-18
K234011 — AMF TT ConesLima Corporate S.P.A.·Product code JWH·2024-01-18
K234031 — Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP·Product code HRS·2024-01-18
K234040 — TriMed Threaded Intramedullary Nail SystemTriMed, Inc.·Product code HWC·2024-01-18
K234051 — Minuteman G5 MIS Fusion Plate +3 moreSpinal Simplicity, LLC·Product code PEK·2024-01-18
K231135 — Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd.·Product code FGB·2024-01-17
K231871 — Radify TriageEnvisionit Deepai, Ltd.·Product code QFM·2024-01-17
K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50Co-Innovation Biotech Co., Ltd.·Product code LDJ·2024-01-17
K233031 — M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy NeedleCanyon Medical, Inc.·Product code KNW·2024-01-17
K233226 — FlexView Diagnostic (v1.1.20)Radical Imaging, LLC·Product code LLZ·2024-01-17
K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular CatheterIntegra Lifesciences Production Corporation·Product code JXG·2024-01-17
K233710 — Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.·Product code PGT·2024-01-17
K233730 — Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew·Product code MBI·2024-01-17
K233783 — exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsPeca Labs, Inc.·Product code DSY·2024-01-17
K233988 — Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.·Product code NRY·2024-01-17
K234030 — Clear Guide SCENERGYClear Guide Medical·Product code JAK·2024-01-17
K223234 — Delta4 InsightScandidos AB·Product code IYE·2024-01-16
K223266 — Hilzo Esophageal StentsThoracent, Inc.·Product code ESW·2024-01-16
K231138 — Aniti-Snore Mouthguard+Oscimed SA·Product code LRK·2024-01-16
K231144 — WashtraysDentsply Sirona·Product code KCT·2024-01-16
K232062 — Uni-portDalim Medical Corp.·Product code OTJ·2024-01-16
K232355 — Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.·Product code GAP·2024-01-16
K233293 — Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®Neurosigma, Inc.·Product code QGL·2024-01-16
K233512 — Rapid (6.0)Ischemaview, Inc.·Product code QIH·2024-01-16
K233796 — Disposable safety lancet (Impress) +4 moreSteriLance Medical (Suzhou), Inc.·Product code FMK·2024-01-16
K233970 — Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)Nephron Nitrile, LLC·Product code LZA·2024-01-16
K232350 — Stryker Facial iD SystemStryker Craniomaxillofacial·Product code JEY·2024-01-13
K233216 — CLEWICU SystemClew Medical , Ltd.·Product code QNL·2024-01-13
DEN220040 — FibresolveImvaria, Inc.·Product code QWO·2024-01-12
DEN230008 — DermaSensorDermasensor, Inc.·Product code QZS·2024-01-12
DEN230015 — Osteoboost BeltBone Health Technologies, Inc.·Product code QZO·2024-01-12
K222783 — MD Mattress Suture Placement DeviceLsi Solutions, Inc.·Product code GCJ·2024-01-12
K231315 — Velox Power ChairVelox Manufacturing, Inc.·Product code ITI·2024-01-12
K231371 — BEE Cervical CageNGMedical GmbH·Product code ODP·2024-01-12
K231558 — SMB Luer lock disposable syringeSmb Corporation of India·Product code FMF·2024-01-12
K231684 — Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.·Product code HRS·2024-01-12
K231820 — SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production·Product code QOG·2024-01-12
K231970 — PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-DockPentax of America, Inc.·Product code EOQ·2024-01-12
K232032 — PROBEAT-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha·Product code LHN·2024-01-12
K232170 — Ti Link AbutmentIzenimplant Co., Ltd.·Product code NHA·2024-01-12
K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)) +2 moreDevicor Medical Products, Inc.·Product code NEU·2024-01-12
K232970 — Hem-o-lok® Ligating ClipsTeleflex Medical·Product code FZP·2024-01-12
K232990 — ATOMIC Nitinol Fixation SystemRmr Ortho, LLC·Product code JDR·2024-01-12
K233020 — TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC·Product code HIF·2024-01-12
K233022 — Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallOwens & Minor (O&M) Halyard, Inc.·Product code MSH·2024-01-12
K233114 — LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited·Product code OHS·2024-01-12
K233125 — Zirconia BlockHangzhou Ivista Medical Devices Co., Ltd.·Product code EIH·2024-01-12
K233141 — SmartFrame ORClearPoint Neuro, Inc.·Product code HAW·2024-01-12
K233144 — ClearPoint Bone Screw FiducialsClearPoint Neuro, Inc.·Product code HAW·2024-01-12
K233155 — ClearPointer Optical Navigation WandClearPoint Neuro, Inc.·Product code HAW·2024-01-12
K233355 — Cypris eXact Suturing SystemCypris Medical·Product code GAW·2024-01-12
K233520 — Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and FentanylAnhui Powerguard Technology Co., Ltd.·Product code LZA·2024-01-12
K233677 — Biograph VK10Siemens Medical Solutions USA, Inc.·Product code KPS·2024-01-12
K233694 — Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation·Product code MAX·2024-01-12
K233964 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)Cosmo Artificial Intelligence - Ai, Ltd.·Product code QNP·2024-01-12
DEN220066 — BrainSeeDarmiyan, Inc.·Product code QWT·2024-01-11
K222929 — ToxiSeal Vial Adapter with External BalloonEpic Medical Pte. , Ltd.·Product code ONB·2024-01-11
K231088 — Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd.·Product code FRO·2024-01-11
K231633 — Disposable Hemoclip (AF series)Alton (Shanghai) Medical Instruments Co., Ltd.·Product code PKL·2024-01-11
K231774 — CoralView® Single-use Digital Flexible Ureteroscope (6 models)MacroLux Medical Technology Co., Ltd.·Product code FGB·2024-01-11
K232250 — SurgiCount+ SystemStryker Instruments·Product code PBZ·2024-01-11
K232285 — U-Lite PROSonoscanner Sarl·Product code IYN·2024-01-11
K232995 — Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005 +4 moreShenzhen Roundwhale Technology Co. , Ltd.·Product code GXY·2024-01-11
K233616 — Clevaligner Software (V1.0.0)Clevaligner, Ltd.·Product code PNN·2024-01-11
K233664 — IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)Shenzhen Ulike Smart Electronics Co., Ltd.·Product code OHT·2024-01-11
K233712 — PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.·Product code MBF·2024-01-11
K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH·Product code JAA·2024-01-11
K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)Hangzhou Laihe Biotech Co., Ltd.·Product code LDJ·2024-01-10
K232955 — Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.·Product code HCG·2024-01-10
K233364 — Axon TherapyNeuralace Medical, Inc.·Product code QPL·2024-01-10
K233902 — Centurion Vision System (Active Sentry) (8065753057)Alcon Laboratories, Inc.·Product code HQC·2024-01-10
K233903 — Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.·Product code HAW·2024-01-10
K233944 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics , Ltd.·Product code NKB·2024-01-10
K232312 — GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.·Product code DSY·2024-01-09
K232597 — 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.·Product code DJG·2024-01-09
K232710 — Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd.·Product code OAS·2024-01-09
K233327 — 1788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy·Product code GCJ·2024-01-09
K231324 — DASI Dimensions (V1.0)Dasi Simulations·Product code QIH·2024-01-08
K232106 — Air Gap FiberWontech Co., Ltd.·Product code GEX·2024-01-08
K232412 — LungQ v3.0.0Thirona BV·Product code JAK·2024-01-08
K232894 — HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)Owens & Minor (O&M) Halyard, Inc.·Product code FXX·2024-01-08
K233035 — Electronic Muscle Stimulator (Model MP01)Shenzhen Hengbosi Industrial Co., Ltd.·Product code NGX·2024-01-08
K233444 — InkSpace Imaging Small Body ArrayInkspace Imaging, Inc.·Product code MOS·2024-01-08
K233615 — Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1Baisheng Medical Co., Ltd.·Product code GEI·2024-01-08
K231068 — autoSCOREHolberg Eeg AS·Product code OMB·2024-01-07
K231608 — Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.·Product code DQY·2024-01-07
K232721 — Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.·Product code DTE·2024-01-07
K221766 — SolonLmg Lasers Comercio, Importacao E Exportacao Ltda·Product code GEX·2024-01-05
K231163 — HS Fiber SuturesRiverpoint Medical·Product code GAT·2024-01-05
K231263 — Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited·Product code EBF·2024-01-05
K231273 — ArcherQA (V1.0)Wisdom Technologies., Inc.·Product code IYE·2024-01-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.