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
RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large
Smith and Nephew Medical Limited
NeuroMatch
LVIS Corporation
MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs
Mentor Worldwide, LLC
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
Boston Scientific Neuromodulation
FreedomFlow Orbital Circumferential Atherectomy System
Cardio Flow Inc.,
INOSS System
Inosys, Inc.
Merlin Aspiration System
Mivi Neurovascular, Inc.
Alma TED+ System
Alma Lasers, Inc.
BreathID Hp Lab System, BreathID Smart System
Meridian Bioscience Israel , Ltd.
Access anti-HAV IgM
Beckman Coulter, Inc.
Chromix
Termosalud S.L.
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
Wrp Asia Pacific Sdn. Bhd.
STA- NeoPTimal
Diagnostica Stago S.A.S
Wearable Breast Pump (Model S21)
Shenzhen TPH Technology Co., Ltd.
POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP
Boston Scientific Corporation
Bloomlife MFM-Pro
Bloom Technologies NV
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
Ineo Tech Sdn Bhd
NeuroQuant PET
Cortechs Labs, Inc.
InfuLife
First Medical Source, LLC
Mg OSTEOINJECT
Bone Solutions, Inc.
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Perfuze, Ltd.
Leforte MMF System
Jeil Medical Corporation
ReneuRx (Neural Ice)
Brixton Biosciences
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
Church & Dwight Co., Inc.
Vathin® Video Bronchoscope System
Hunan Vathin Medical Instrument Co., Ltd.
The SensiTox B. anthracis Toxin Test
First Light Diagnostics, Inc.
DELPHI System
CnS Medical Co., Ltd.
Non Sterile Nitrile Powder Free Examination Gloves Blue, Green and Black color
Mexpo International, Inc.
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
Shenzhen Greatro Electronic Technology Co., Ltd.
Terragene® Bionova® BT20 Biological Indicator
Terragene
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