510(k) Clearances — Page 175

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 175 of 3,525)
ClearancesDetails
K231371 — BEE Cervical CageNGMedical GmbH Jan 12, 2024
K231315 — Velox Power ChairVelox Manufacturing, Inc. Jan 12, 2024
K231558 — SMB Luer lock disposable syringeSmb Corporation Of India Jan 12, 2024
K233020 — TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC Jan 12, 2024
DEN230008 — DermaSensorDermasensor, Inc. Jan 12, 2024
K232990 — A’TOMIC™ Nitinol Fixation SystemRmr Ortho, LLC Jan 12, 2024
K233125 — Zirconia BlockHangzhou Ivista Medical Devices Co., Ltd. Jan 12, 2024
K233677 — Biograph VK10Siemens Medical Solutions USA, Inc. Jan 12, 2024
K232032 — PROBEAT-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Jan 12, 2024
DEN230015 — Osteoboost BeltBone Health Technologies, Inc. Jan 12, 2024
K232170 — Ti Link AbutmentIzenimplant Co., Ltd. Jan 12, 2024
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. Jan 12, 2024
K233155 — ClearPointer Optical Navigation WandClearPoint Neuro, Inc. Jan 12, 2024
K232970 — Hem-o-lok® Ligating ClipsTeleflex Medical Jan 12, 2024
K231684 — Quick - Radius Disposable SetGM Dos Reis Industria E Comercio Ltda. Jan 12, 2024
K233141 — SmartFrame ORClearPoint Neuro, Inc. Jan 12, 2024
K233694 — Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation Jan 12, 2024
K231820 — SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production Jan 12, 2024
K233520 — Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and FentanylAnhui Powerguard Technology Co., Ltd. Jan 12, 2024
DEN220040 — FibresolveImvaria, Inc. Jan 12, 2024
K233114 — LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited Jan 12, 2024
K232995 — Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; ElectrotheShenzhen Roundwhale Technology Co. , Ltd. Jan 11, 2024
K233616 — Clevaligner Software (V1.0.0)Clevaligner, Ltd. Jan 11, 2024
K233712 — PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. Jan 11, 2024
DEN220066 — BrainSeeDarmiyan, Inc. Jan 11, 2024
K232250 — SurgiCount+ SystemStryker Instruments Jan 11, 2024
K231088 — Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd. Jan 11, 2024
K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH Jan 11, 2024
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. Jan 11, 2024
K232285 — U-Lite PROSonoscanner Sarl Jan 11, 2024
K222929 — ToxiSeal Vial Adapter with External BalloonEpic Medical Pte. , Ltd. Jan 11, 2024
K231633 — Disposable Hemoclip (AF series)Alton (Shanghai) Medical Instruments Co., Ltd. Jan 11, 2024
K231774 — CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)MacroLux Medical Technology Co., Ltd. Jan 11, 2024
K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)Hangzhou Laihe Biotech Co., Ltd. Jan 10, 2024
K233364 — Axon TherapyNeuralace Medical, Inc. Jan 10, 2024
K233944 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics , Ltd. Jan 10, 2024
K233903 — Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. Jan 10, 2024
K232955 — Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. Jan 10, 2024
K233902 — Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc. Jan 10, 2024
K232312 — GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. Jan 9, 2024
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. Jan 9, 2024
K232710 — Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. Jan 9, 2024
K233327 — 1788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy Jan 9, 2024
K233035 — Electronic Muscle Stimulator (Model MP01)Shenzhen Hengbosi Industrial Co., Ltd. Jan 8, 2024
K231324 — DASI Dimensions (V1.0)Dasi Simulations Jan 8, 2024
K232412 — LungQ v3.0.0Thirona BV Jan 8, 2024
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. Jan 8, 2024
K232106 — Air Gap FiberWontech Co., Ltd. Jan 8, 2024
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. Jan 8, 2024
K233444 — InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. Jan 8, 2024
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