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
Sonata Transcervical Fibroid Ablation System 2.2
Gynesonics, Inc.
Hood (DH-083ST)
Fujifilm Corporation
Elecsys Phospho-Tau (217P) Plasma
Roche Diagnostics
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 36
Cardiovascualr Systems, Inc.
ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON
Ethicon Endo-Surgery
Vital Spinal Fixation System
Zimvie Spine (Zimmer Biomet Spine, Inc.)
ReFlow System Mini
Anuncia Medical, Inc.
Fogg System Patient Monitoring Cables
Fogg System Company, Inc.
Access OV Monitor
Beckman Coulter, Inc.
AIRAscore
Airamed GmbH
Humerus & Ulna System
Auxein Medical Private Limited
Augmented Gingival Matrix
Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
Sleep Watch
Ambulatory Monitoring, Inc.
AB1 Electrosurgical Instrument, Creo Electrosurgical System
Creo Medical, Ltd.
Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
Imperative Care, Inc.
Aventus Introducer Sheath
Inquis Medical
Mobility Scooter (W3483, W3483A)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
BriefCase-Triage
Aidoc Medical , Ltd.
NeuroMatch
LVIS Corporation
MASADA Modular Spinal Fixation System
Astura Medical
Duet Spinal Fixation System
Box Spine, LLC
Surgical Isolation Cover Gown
Wuhan Dymex Healthcare Co., Ltd.
LMNT O2
Xplr , Ltd.
GSS610N21 Series Steam Sterilizer
Maquet GmbH
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
Meditrina, Inc.
MedtFine Blood Lancet
Shanghai Carelife International Trading Co. , Ltd.
Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endoveno
Acotec Scientific Co., Ltd.
CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation
FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix B
Prosidyan, Inc.
Reliance Cervical IBF System
Reliance Medical Systems, LLC
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