510(k) Clearances — Page 140

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 140 of 3,525)
ClearancesDetails
K240724 — SynthVISION 1.0.0Synthesis Health Intelligence, Inc. Aug 8, 2024
K240229 — Masimo W1Masimo Corporation Aug 8, 2024
K233315 — HipXpert and HipInsight SystemSurgical Planning Associates, Inc. Aug 8, 2024
K242009 — 360CAS KneeKico Knee Innovation Company Pty, Ltd. Aug 8, 2024
K233844 — OdneCleanOdne AG Aug 8, 2024
K231775 — GR Resin System MSIPro3Dure Medical Aug 8, 2024
K240255 — Electric Wheelchair (JLE-W01A-2023)Zhejiang Jianrui Technology Company Limited Aug 7, 2024
K241685 — SofWave SystemSofwave Medical, Ltd. Aug 7, 2024
K233606 — ADVIA Centaur EBV-VCA IgMBiokit, S.A. Aug 7, 2024
K241530 — Stellar Imaging SystemGuangdong Optomedic Technologies, Inc. Aug 7, 2024
K241644 — SPINEART Navigation Instrument SystemSpineart SA Aug 7, 2024
K240605 — Ultra RapidWarm™ BlastVitrolife Sweden AB Aug 7, 2024
K233605 — ADVIA Centaur EBV-EBNA IgGBiokit, S.A. Aug 7, 2024
K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic Aug 7, 2024
K212969 — LiposaverLhbiomed Co., Ltd. Aug 7, 2024
K240330 — HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)O&M Halyard, Inc. Aug 7, 2024
K241708 — Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. Aug 6, 2024
K241528 — Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis PotentialComfort Rubber Gloves Industries Sdn. Bhd. Aug 6, 2024
K233920 — EOSedgeEos Imaging Aug 6, 2024
K240796 — myAblation Guide (VB80A)Siemens Healthcare GmbH Aug 6, 2024
K233577 — Sleepio®Big Health, Inc. Aug 5, 2024
K240932 — HybridTherm SystemErbe Elektromedizin GmbH Aug 5, 2024
K233761 — Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical , Ltd. Aug 5, 2024
K233992 — Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. Aug 5, 2024
K240127 — PlumeSafe X5 Smoke Management SystemConmed Corporation Aug 5, 2024
K233653 — Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLC Aug 5, 2024
K241360 — Universal Seal (5-12 mm)Intuitive Surgical, Inc. Aug 5, 2024
K241635 — da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical Aug 5, 2024
K240953 — AI Platform 2.0 (AIP002)Exo Imaging Aug 5, 2024
K240782 — CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)Pulse Biosciences, Inc. Aug 5, 2024
K233534 — Viral Transport MediumHardy Diagnostics Aug 2, 2024
K233706 — Bendini Cloud ApplicationNuvasive Aug 2, 2024
K241621 — Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical Aug 2, 2024
K241642 — Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd. Aug 2, 2024
K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics Aug 2, 2024
K241892 — Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. Aug 2, 2024
K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation Aug 2, 2024
K233098 — MYOTouch Muscle StimulatorSunmed, LLC Aug 2, 2024
K241918 — MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC Aug 2, 2024
K233984 — Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC Aug 2, 2024
K241311 — Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)Bernhard Förster GmbH Aug 2, 2024
K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd. Aug 2, 2024
K233571 — GCI Surgical GownGeorge Courey, Inc. Aug 2, 2024
K233798 — Moda-flx Hemodialysis System and CartridgeDiality, Inc. Aug 2, 2024
K233601 — Fixone Meniscal RepairAju Pharm Co., Ltd. Aug 2, 2024
K242008 — Coronis OneLookBarco N.V. Aug 2, 2024
K240909 — Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd. Aug 2, 2024
K241359 — Medline UNITE® MIS Foot Recon Screw SystemMedline Industries, LP Aug 2, 2024
K240981 — Air compression leg massagerHuizhou Xinyi Technology Co., Ltd. Aug 2, 2024
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 Aug 2, 2024
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