510(k) Clearances — Page 125
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241708 — Abiomed 14Fr Low Profile Introducer Kit | Abiomed, Inc. Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233920 — EOSedge | Eos Imaging Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240796 — myAblation Guide (VB80A) | Siemens Healthcare GmbH Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233577 — Sleepio® | Big Health, Inc. Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240127 — PlumeSafe X5 Smoke Management System | Conmed Corporation Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240932 — HybridTherm System | Erbe Elektromedizin GmbH Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233761 — Orthopaedic Surgery Planning Software (AIJOINT) | Longwood Valley Medical , Ltd. Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241360 — Universal Seal (5-12 mm) | Intuitive Surgical, Inc. Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241635 — da Vinci E-200 Electrosurgical Generator | Intuitive Surgical Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240953 — AI Platform 2.0 (AIP002) | Exo Imaging Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233992 — Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. 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) |
| 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) |
| K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS | Baxter Healthcare Corporation 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) |
| K233534 — Viral Transport Medium | Hardy Diagnostics 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) |
| K241918 — MENTOR CPX4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233571 — GCI Surgical Gown | George Courey, Inc. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241892 — Cortera Spinal Fixation System | Xtant Medical Holdings, Inc. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233601 — Fixone Meniscal Repair | Aju Pharm Co., Ltd. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233098 — MYOTouch Muscle Stimulator | Sunmed, LLC Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233706 — Bendini Cloud Application | Nuvasive Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233798 — Moda-flx Hemodialysis System and Cartridge | Diality, Inc. 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) |
| K233984 — Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC 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) |
| K242008 — Coronis OneLook | Barco N.V. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241359 — Medline UNITE® MIS Foot Recon Screw System | Medline Industries, LP Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240981 — Air compression leg massager | Huizhou 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 Test | Innovita (Tangshan) Biological Technology Co., Ltd. Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241181 — Disposable Ureteral Guide Sheath | Dongguan Zsr Biomedical Technology Company Limited Fri Aug 02 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) |
| DEN230046 — PGDx elio plasma focus Dx | Personal Genome Diagnostics, Inc. 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) |
| K241105 — 3MP Color LCD Monitor (CL-S301) | Jvckenwood Corporation Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240035 — TACTIX Vector Syndesmosis System | Vilex, LLC Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232469 — Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234141 — AISAP Cardio V1.0 | Aisap Thu Aug 01 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) |
| K242055 — Freefix Forearm Plating System | Skeletal Dynamics, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233731 — CardIQ Suite | GE Medical Systems SCS 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 System | CarboFix Orthopedics , Ltd. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240312 — Infinity CentralStation Wide | Draeger 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) |