510(k) Clearances

174,759 clearances total

K233992 — Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240127 — PlumeSafe X5 Smoke Management SystemConmed Corporation Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240782 — CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)Pulse Biosciences, Inc. Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233984 — Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241621 — Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233571 — GCI Surgical GownGeorge Courey, Inc. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233098 — MYOTouch Muscle StimulatorSunmed, LLC Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241892 — Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233706 — Bendini Cloud ApplicationNuvasive Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233798 — Moda-flx Hemodialysis System and CartridgeDiality, Inc. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241918 — MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241642 — Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233601 — Fixone Meniscal RepairAju Pharm Co., Ltd. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242008 — Coronis OneLookBarco N.V. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240909 — Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241359 — Medline UNITE® MIS Foot Recon Screw SystemMedline Industries, LP Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240981 — Air compression leg massagerHuizhou Xinyi Technology Co., Ltd. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241970 — Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)Kanglongda Vietnam Protection Technology Company Limited Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241919 — Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233534 — Viral Transport MediumHardy Diagnostics Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241311 — Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)Bernhard Förster GmbH Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241181 — Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233580 — A Breathing System (ABS)Deepwell Dtx, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234141 — AISAP Cardio V1.0Aisap Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241105 — 3MP Color LCD Monitor (CL-S301)Jvckenwood Corporation Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241145 — TLAB® Transvenous Liver Biopsy System (TF-18C)Argon Medical Devices, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240035 — TACTIX Vector Syndesmosis SystemVilex, LLC Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232469 — Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240301 — MammoScreen® (3)Therapixel Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242055 — Freefix Forearm Plating SystemSkeletal Dynamics, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233731 — CardIQ SuiteGE Medical Systems SCS Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
DEN230046 — PGDx elio plasma focus DxPersonal Genome Diagnostics, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241238 — LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233793 — CarboClear® X Pedicle Screw SystemCarboFix Orthopedics , Ltd. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240312 — Infinity CentralStation WideDraeger Medical Systems, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241945 — KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)Karl Storz SE & CO. KG Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242046 — EXULT Knee Replacement SystemCorentec Co., Ltd. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241140 — ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLC Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )Pentax of America, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233696 — DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241690 — Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241137 — Clear Moves AlignerClear Moves Aligners Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241934 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)Anx Robotica Corp Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240967 — ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240898 — SteriTite rigid reusable sterilization container with MediTray ProductsCase Medical Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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