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
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Perfadex Plus
Xvivo Perfusion AB
Pterygoid Indication for GM Helix Implants
JJGC Indústria e Comércio de Materiais Dentários S.A.
BioFire Warrior Panel; BioFire Warrior Panel Control Kit
Biofire Defense, LLC
GAL-1A Plus Blood Glucose Monitoring System
Apex BioTechnology Corp.
BD Trek Powered Bone Biopsy System
Bard Peripheral Vascular
Fetal Doppler
Shenzhen Mericonn Technology Co., Ltd.
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTr
Stryker Spine
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Inomed Medizintechnik GmbH
Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
Excellent Medical Technology Group Co., Ltd.
Hair Growth Laser Cap
Cosmo Far East Technology Limited
Access Vitamin B12
Beckman Coulter, Inc.
NYES Tuff Cuff L3 Disposable Gowns
New York Embroidery Studio
ProNephro AKI (NGAL)
Bioporto Diagnostic, Inc.
Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
Shenzhen AOJ Medical Technology Co., Ltd.
Monopolar Electrode Surgical Instrument
Vhmed (Nantong) Co. , Ltd.
Samfilcon B Custom Contact Lens
Bausch + Lomb, Incorporated
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana, Inc.
RevCore Thrombectomy Catheter.
Inari Medical, Inc.
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
Baxter Healthcare Corporation
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
Ningxia Qiaoen Medical Technology Co., Ltd.
Disposable Sterile Lancet
Tianjin Rilifine Medical Device Co., Ltd.
Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co. , Ltd.
HyperVue Imaging System - Integrated
Spectrawave, Inc.
ELEOS Limb Salvage System with NanoCept® Technology
Onkos Surgical, Inc.
Manual Wheelchair
Lichtmega Technology Co., Ltd.
Xenco Medical Multilevel CerviKit
Xenco Medical, LLC
Intelligent NR
Canon, Inc.
SOMAVAC 100 Sustained Vacuum System
Somavac Medical Solutions, Inc.
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Genesee Biomedical, Inc.
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