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
CELERITY HP Indicator Tape (PCC077)
Steris
Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
D·Kutting PTA Scoring Balloon Dilatation Catheter
Dk Medical Technology Co., Ltd.
Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle
Shandong Zhushi Pharmaceutical Group Co., Ltd.
eFOLDi Scooter, Lite
Suntech UK , Ltd.
Nitrile Examination Gloves
Ecoglove Medical Manufacturing Company Limited
Solidex® Ti-Links and Screws
CreoDent Hudson Valley
Montross Extremity Medical Hemi Implant System
Montross Extremity Medical
Hemoclip
Hangzhou AGS MedTech Co., Ltd.
IU Implant System Abutment
Warantec Co., Ltd.
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
Candela Corporation
Respiree Cardio- Respiratory Monitor System
Respiree Pte, Ltd.
Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Tria
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
CEFALY Connected - OTC, CEFALY Connected - Rx
Cefaly Technology
ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)
Globus Medical, Inc.
PRAEVAorta®2
Nurea
Restrata Soft Tissue Reinforcement (STR)
Acera Surgical, Inc.
Electric Wheelchair (0080)
Xuzhou Heabens Medical Technology Co., Ltd.
SPY Laparoscope
Stryker Endoscopy
Sonix Health
Ontact Health Co., Ltd.
MX50N
Wide Corporation
OtoCompanion (Version 1.0)
Ironsides Medical, Inc.
MIM Dose Analysis
Mim Software, Inc.
Wolff's Law Anterior Cervical Plate System
Spinal Simplicity, LLC
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoje
Cardinalhealth
TENSOR® Suture Button System
Globus Medical, Inc.
Eonis SCID-SMA kit
Perkinelmer, Inc.
TeleRehab Aermos Cardiopulmonary Rehabilitation
The ScottCare Corporation
Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle,
Jiangsu Rongye Technology Co., Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert