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
VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Ma
Acist Medical Systems, Inc.
Ivory Glove Powder-Free Nitrile Examination Gloves
Ivory Gloves Sdn. Bhd.
SoftSpot
Pediametrix, Inc.
Dental Implant Unit
Guilin Aesthedent Medical Instruments Co., Ltd.
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
Medimaging Integrated Solution, Inc (Miis)
Celebrace Software
Celebrace
Acumed Wrist Plating System
Acumed, LLC
Bridge Plus Occlusion Balloon (590-002)
Philips Image Guided Therapy Devices
Humask Pro Vision, Humask Pro Vision 3000
Entreprise Premont, Inc.
QOCA Portable ECG Monitoring Device
Quanta Computer, Inc.
Vinyl/Nitrile Blend Exam Glove
Dezhou Hengchang Medical Technology Co., Ltd.
REGER Nebulizer Irrigation Cannula
Reger Medizintechnik, GmbH
Disposable Radiofrequency Cannula
ABBOTT MEDICAL
Revi System
Bluewind Medical , Ltd.
Diode Laser Hair Removal System (SH-VD910)
Beijing Sea Heart International Science and Technologyco.Ltd
Safety Insulin Pen Needles
Zhejiang Kindly Medical Devices Co., Ltd.
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Canon Medical Systems Corporation
Bullsai Confirm
Turing Medical Technologies, Inc.
EchoNavigator R4.0
Philips Medical Systems Nederland B.V.
TORPEDO Implant System®
Deltacor GmbH
Wrist Blood Pressure Monitor, Blood Pressure Monitor
Andon Health Co, Ltd.
Safecare Urinary Tract Infection Test
Safecare Biotech (Hangzhou) Co., Ltd.
MIRA Surgical System
Virtual Incision
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
Boston Scientific
Augmented Gingival Matrix
Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
Powered Wheelchair (NXN20-208, NXN20-211)
Zhejiang Nysin Medical Co., Ltd.
Quell-FM
Neurometrix, Inc.
1 Series Phototherapy Equipment
Daavlin Distributing Co.
SP-CL Hip Stem and LCU Hip System
Waldemar Link GmbH & Co. KG
EOlife®
Archeon
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