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
RadiForce GX570; RadiForce GX570-AR
Eizo Corporation
Consensus Knee System with TiNbN
Shalby Advanced Technologies
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
Grand Work Plastic Products Co., Ltd.
N Series Patient Monitors
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
GMK Sphere Revision
Medacta International S.A.
X-Smart Pro; X-Smart Pro+
Dentsply Sirona, Inc.
Disposable Automatic Core Biopsy Instrument
Suzhou Leapmed Healthcare Corporation
LINQ II Insertable Cardiac Monitor
Medtronic, Inc.
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
Spectrum Medical S.R.L.
OCS Lung Solution
TransMedics, Inc.
SAYA 86 Radial Access Guide Catheter
Asahi Intecc Co., Ltd.
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
Hivox Biotek, Inc.
TruWave Disposable Pressure Transducer
Edwards Lifesciences, LLC
Noodle
Pourang Bral, Dds, LLC
Myomics
Phantomics, Inc.
Altus Spine Sochi OCT Spinal System
Altus Partners, LLC
Neurovascular Insight V1.0
Olea Medical S.A.S.
CardioTag
Cardiosense, Inc.
IceCap product line
Bioserenity Medical Devices Group
OsteoCool 2.0 RF Ablation System
Medtronic Sofamor Danek USA, Inc.
Disposable Endobronchial Blocker Tube
Shenzhen Insighters Medical Technology Co., Ltd.
Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)
Shanghai Bangbang Robotics Co., Ltd.
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Neuronetics, Inc.
TumorSight Viz
SimBioSys, Inc.
SITTER 3.5mm Versatile System
Bonebridge AG
Ambu® Virobac II® Exhalation Filter
Ambu A/S
CONDUIT ZERO-P VA Secured Spacer System
Avalign Technologies, Inc.
OEC One ASD
Ge Hualun Medical Systems Co. , Ltd.
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
STERIS Corporation
Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
Cotton High Tech S.L.
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