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
Vitesse (5.0)
Varian Medical Systems
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Pow
Dehai (Shandong) Medical Gloves, Co., Ltd.
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
Lucens Technology Co., Ltd.
Aurora
Ensodata
Skyway Anterior Cervical Plate System
Kyocera Medical Technologies, Inc.
AliTight
Alic Iotech, LLC
Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Xpert Carba-R
Cepheid®
Augment Off-Axis Instrument System
Fix Surgical
IRNF App
Apple, Inc.
MSS - Humeral reverse liners extension
Medacta International S.A.
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse P
Wuhan United Imaging Healthcare Co.,Ltd
Percutaneous Endoscopic Gastrostomy (PEG) Kit
Degania Silicone , Ltd.
MAGiC Sweep EP Mapping Catheter
Stereotaxis, Inc.
FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
Fujifilm Corporation
XO CROSS CORONARY Support Catheter
Transit Scientific, LLC
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
Contamac, Ltd.
uMR Omega with uWS-MR-MRS
Shanghai United Imaging Healthcare Co., Ltd.
Mochida Nerve Cuff
Mochida Pharmaceutical Co., Ltd.
Bright MTA Sealer Plus
Genoss Co., Ltd.
Sentient Manufacturing Laser Fiber
Sentient Manufacturing , LLC
Bioline Dental Implant System
Bioline Dental Implant Systems, Ltd.
BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
Suzhou Sniper Medical Technologies Co., Ltd.
25G Huber Needle
Martech Medical Products
NeuroBlate System
Monteris Medical,
LOCATOR Angled Abutment
Zest Anchors, LLC
AEON Endoscopic Stapler
Lexington Medical, Inc.
MU System
Dentis Co., Ltd.
DePuy Synthes 3.5mm Intrapelvic Acetabular System
DePuy Synthes
Hercules Syndesmosis Implant System
In2bones USA, LLC
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