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
Pediatric Nailing Platform Femur
OrthoPediatrics Corp.
CCBIO ASCPO Needle
Cc Biotechnology Corporation
Ultrasound System SONIMAGE MX1
Konica Minolta, Inc.
ARTSMedia Semen Wash Medium
Artsmedia Denmark Aps
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
Paragon Vision Sciences, Inc.
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co. , Ltd.
Nitrile Patient Examination Glove
American Performance Polymers, LLC
uDR 380i Pro
Shanghai United Imaging Healthcare Co., Ltd.
Vinyl Powder Free Examination Glove
Top Glove Vietnam Company Limited
PENTAX Medical Video Upper GI Scopes EG17-J10
Pentax of America, Inc.
PuraStat
3-D Matrix Europe SAS
KALA MINI 2.0 (KALA-04)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
14Fr Low Profile Introducer Kit
Abiomed, Inc.
Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143
Shenzhen Yicai Health Technology Co., Ltd.
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 0
Infraredx, Inc.
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
Spectrum Medical S.R.L.
Dib UltraNav Transseptal Catheter System
Dib Ultranav Medical, LLC
Myopia Master
Oculus Optikgeräte GmbH
9Line
Energetic Designs, Inc.
MIRARI® Cold Plasma System ( GV-M2-01)
General Vibronics, Inc.
Miria Skin Treatment System
AVAVA, Inc.
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
Sysmex America, Inc.
Penumbra System (Thunderbolt Aspiration Tubing)
Penumbra, Inc.
icotec Anterior Cervical Plate System
Icotec AG
TempFIT Temporary Crown and Bridge Resin
Rizhao Huge Biomaterials Company, Ltd.
UNITY Sacroiliac Joint Fixation System
Dio Medical Corporation
AccuFFRangio
ArteryFlow Technology Co., Ltd.
TR BAND Radial Compression Device
Terumo Medical Corporation
Standard Staple-Line Reinforcement (SSLR23)
Standard Bariatrics, Inc.
cobas liat CT/NG/MG nucleic acid test
Roche Molecular Systems, Inc.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert