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
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert