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
RCT700
Ray Co., Ltd.
Summit Patella Plating System
Endeavor Orthopaedics, LLC
iFuse INTRA Ti Implant System
SI-BONE, Inc.
Plaxpot Multi Plasma
Gcs Co. Limited
Disposable surgical face mask
Shandong Aida Medical Products Co., Ltd.
ProxiDiagnost N90
Philips Medical Systems Dmc GmbH
Equinoxe® Shoulder System
Exactech, Inc.
EW10-EC02 Endoscopy Support Program
Fujifilm Corporation
TheraSphere 360 Y-90 Management Platform
Boston Scientific Corporation
ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® E
Aneuvo
APO-Easy Genotyping kit
Firalis SA
Sunrise
Sunrise SA
LANDR Contact LENS Case
Fourth Axis, LLC
Vassallo GT 018 Hybrid
Filmecc Co., Ltd.
Enteral Feeding Set
Kb Medical (Group), Inc.
Med-link Disposable ECG Cable and Leadwires
Shenzhen Med-Link Electronics Tech Co., Ltd.
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
Shenzhen Kentro Medical Electronics Co., Ltd.
Active-V Total Knee System; World Total Knee System
Signature Orthopaedics Pty, Ltd.
Diode laser therapy device (VADER)
Beijing Superlaser Technology Co., Ltd.
PicoStar
Asclepion Laser Technologies GmbH
EK Digital Abutments
Hiossen, Inc.
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Bloomden Bioceramics (HuNan) Co., Ltd.
Curiteva Porous PEEK Standalone ALIF System
Curiteva, Inc.
Calibrate LTX Interbody System
Alphatec Spine, Inc.
ELEC ENGINE (Model: ISE-170L)
Micro-Nx Co., Ltd.
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as
Covidien, LLC
Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libert
Integra Lifesciences Production Corporation
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
Kyocera Medical Technologies, Inc.
Maestro System (REF100)
Moon Surgical
Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
Shenzhen Sontu Medical Imaging Equipment Co., Ltd.
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