510(k) Clearances — Page 150

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 150 of 3,525)
ClearancesDetails
K240516 — RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jun 12, 2024
K240876 — Identity Shoulder SystemZimmer, Inc. Jun 12, 2024
K240050 — SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc. Jun 12, 2024
K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)Medtronic, Inc. Jun 12, 2024
K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc. Jun 12, 2024
K232950 — Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needlePerfect Medical Industry (Vn) Co., Ltd. Jun 12, 2024
K233007 — Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. Jun 12, 2024
K240256 — Remunity SystemDeka Research And Development Jun 12, 2024
K233610 — ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc. Jun 12, 2024
K240504 — PLASMA EDGE SystemLamidey Noury Medical Jun 12, 2024
K233613 — ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Jun 12, 2024
K221547 — InActiv BlueFertipro NV Jun 11, 2024
K241025 — JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. Jun 11, 2024
K241344 — MetriCide™ OPA Plus Solution Test StripSteris Jun 11, 2024
K230546 — SIGNEXOsteonic Co., Ltd. Jun 11, 2024
DEN230069 — Mi-CHORD SystemLsi Solutions, Inc. Jun 11, 2024
K232749 — DOOPANGYbrain, Inc. Jun 11, 2024
K241011 — Mako Total Knee ApplicationMako Surgical Corp. Jun 11, 2024
K240111 — VenueGE Medical Systems Ultrasound And Primary Care Diagnostics Jun 10, 2024
K241399 — Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc. Jun 10, 2024
K233767 — OmniTom EliteNeurologica Corporation Jun 10, 2024
K240644 — Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd. Jun 10, 2024
K240106 — Histofreezer VCryoconcepts LP Jun 10, 2024
K240108 — Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)Gymmax Technology Shenzhen Co., Ltd. Jun 10, 2024
K234106 — Venue FitGE Medical Systems Ultrasound And Primary Care Diagnostics Jun 10, 2024
K232911 — KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)Karl Storz Endovision, Inc. Jun 10, 2024
K240283 — BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)MacroLux Medical Technology Co., Ltd. Jun 10, 2024
K240053 — Venue GoGE Medical Systems Ultrasound And Primary Care Diagnostics Jun 10, 2024
K240206 — Venue SprintGE Medical Systems Ultrasound And Primary Care Diagnostics Jun 10, 2024
K241423 — Access ThyroglobulinBeckman Coulter, Inc. Jun 7, 2024
K241038 — Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging Jun 7, 2024
K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc. Jun 7, 2024
K232625 — Steriking® Pouch for Robotic InstrumentsWipak OY Jun 7, 2024
K232806 — HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)Owens & Minor (O&M) Halyard, Inc. Jun 7, 2024
K240972 — Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)Surgical Instrument Service And Savings, Inc. Jun 7, 2024
K240570 — IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. Jun 7, 2024
K240672 — Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)Zhejiang Zahndent Biotechnology Co., Ltd. Jun 7, 2024
K234042 — EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd. Jun 7, 2024
K234099 — Select Hybrid Personal Lubricant, and Select Pure Silicone Personal LubricantSelect Labs, LLC Jun 7, 2024
K241069 — iLoop Interventional Coil 0.55TNoras Mri Products GmbH Jun 7, 2024
K231010 — CorvairAliveCor, Inc. Jun 7, 2024
K232035 — ImpalaAliveCor, Inc. Jun 7, 2024
K232969 — Disposable Hemostatic ClipsNingbo Xinwell Medical Technology Co., Ltd. Jun 7, 2024
K240832 — Blood Pressure Monitor (BBZ32-AA01)Guangdong Transtek Medical Electronics Co., Ltd. Jun 7, 2024
K232816 — Electrocardiograph, model: ECG301Shenzhen LE Medical Technology Co., Ltd. Jun 7, 2024
K232837 — Uro-G HD Flexible CystoscopeUroviu Corporation Jun 7, 2024
K232804 — FibriCheckQompium NV Jun 7, 2024
K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health Jun 7, 2024
K233861 — Libre Rio Continuous Glucose Monitoring SystemAbbott Diabetes Care Jun 7, 2024
K240662 — Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary HandpieceStryker Leibinger GmbH & Co KG Jun 6, 2024
← Previous Page 150 of 3525 Next →