RecallHawk

510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

InSpace Subacromial Tissue Spacer System

Ortho-Space , Ltd.

Disposable Surgical Gown

Henan Robestain Medical Products Co., Ltd.

SteriHub™ Disinfecting Device and Protective Cover

1World Vista Medical

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

Sb-Kawasumi Laboratories, Inc.

MISTI Silicone Implant

Keosan Trading Co.

Neodent Scannable Healing Abutment

JJGC Indústria e Comércio de Materiais Dentários S.A.

EARP Nerve Cuff Electrode

Retropsoas Technologies, LLC

Talee, Talee PostOP

Invent Medical USA, LLC

Chemical Indicator for enspire CLCSPS (LCC015)

STERIS Corporation

PRIMO S

A.T.S. Applicazione Tecnologie Speciali S.R.L.

Intraoperative Ultrasound Probe Cover

Exact Medical Manufacturing

Hailie Sensor NF0110

Adherium (Nz), Ltd.

Matreneu Percutaneous Balloon Compression Kit

Shenzhen Shineyard Medical Device Co. , Ltd.

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate

Iconic Medicare Sdn Bhd

Bonvadis®

Stemcyte, Inc.

1CMR Pro

Mycardium AI Limited

Ventana™ L Spinal System

Spinal Elements, Inc.

Multistage Balloon Dilatation Catheter

Dongguan TT Medical, Inc.

FX V135 EASYTECH® Shoulder System

FX Shoulder Solutions, Inc.

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter

Reshape Lifesciences

Bio-Medicus Life Support Catheter and Introducer

Medtronic, Inc.

Versana Balance

GE Medical Systems Ultrasound and Primary Care Diagnostics

Zevo Anterior Cervical Plate System

Medtronic Sofamor Danek USA, Inc.

14F iSLEEVE Introducer Set

Boston Scientific Corporation

31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil

Rapid Biomedical GmbH

VXvue

Vieworks Co., Ltd.

Gastro Concepts Air Assist

Gastro Concepts, LLC

WasherCap™ Fixation System

Abanza Tecnomed S.L

AuroLase® System

Nanospectra Biosciences, Inc.

Actively Trying Personal Lubricant Unfragrance

CC Wellness, LLC

← PrevPage 6 of 500Next →

Track 510(k) device clearances

Get notified when new devices are cleared in your category.

Set Up Free Alert