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
Bipolar Coagulation Foreceps
Hangzhou AGS MedTech Co., Ltd.
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope
Pentax of America, Inc.
Sleepio®
Big Health, Inc.
ZEN-2090 Turbo
Genoray Co., Ltd.
Erchonia Zerona® VZ8
Erchonia Corporation
Transpara 1.7.2
Screenpoint Medical B.V.
METIC- Airway Balloon Catheter
M/S Meril Life Sciences Pvt. , Ltd.
Actera hip system
Conformis, Inc.
HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
Depuy Mitek
VBrain
Vysioneer, Inc.
ME-APDS; MAGENTIQ-COLO
Magentiq Eye, Ltd.
SpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.
VenSure LightGuide
Intersect Ent.
Kyphoplasty Balloon Catheter
Jiangsu Changmei Medtech Co., Ltd.
Surgical Masks
Hubei Xinxin Non-Woven Co., Ltd.
Treace Medical Concepts (TMC) Implant Fixation System
Treace Medical Concepts
NPseal
Guard Medical, Inc.
MedCAD® AccuStride System
Medcad
XVbeam2000
Shenzhen Xpectvision Technology Co., Ltd.
FiteBac CC OrthoSeal
Largent Health, LLC
Erbe's Tubing/Cap Sets
Erbe USA, Inc.
TrachCuff Cuff Controller
Aw Technologies Aps
SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
Medtronic, Inc.
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Topzir Biotech Co., Ltd.
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
CMT Health PTE., Ltd.
Scooter (YD-03)
Yurob Rehabilitation Medical Co., Ltd.
Laboratorios Biogalenic Sterile Water for Inhalation, USP
Laboratorios Biogalenic S.A. DE C.V.
APTUS Clavicle System 2.8
Medartis AG
Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0
Boston Scientific Corporation
Shoulder Soft Tissue Anchors
Signature Orthopaedics Pty, Ltd.
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