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
Protect-It Custom Fit Dental Guard
Doc Brands, Inc.
Instrument Case
Cochlear Americas
BriefCase-Triage
Aidoc Medical , Ltd.
Altech® Exhalation Valve (Single Limb and Dual Limb)
Meditera Tibbi Malzeme San VE Tic AS
Nexus DRF Digital X-ray Imaging System
Varex Imaging Corporation
Digital Radiography CXDI-Pro, Digital Radiography D1
Canon, Inc.
Amplatzer Steerable Delivery Sheath
ABBOTT MEDICAL
Vathin® Video Bronchoscope System
Hunan Vathin Medical Instrument Co., Ltd.
PCA Syringe Sets
Baxter Healthcare Corporation
Tomier Perform Reversed Glenoid Cannulated Glenospheres
Tornier, Inc.
Elecsys sFlt-1 and Elecsys PlGF
Roche Diagnostics
Electric Breast Pump
Shenzhen Changkun Technology Co., Ltd.
Elitone for Men
Elidah, Inc.
Valeda Light Delivery System
Lumithera, Inc.
QuickAligners
Oral Image, Inc.
ManaSport+
Manamed, Inc.
Alinity h-series System
Abbott Laboratories
ClearPoint Bone Screw Fiducials
ClearPoint Neuro, Inc.
LifePath Remote Patient Monitoring Platform
Elastic Care Incorporated
OsteoProbe
Active Life Scientific, Inc.
qER-CTA (v1.0)
Qure.Ai Technologies
RODIN Expandable Lumbar Cage System
Ctl Medical Corporation
MX50N
Wide Corporation
WELLTRUST WT-III Mask with Flat Earloop
Lonestar Meadows, LLC
OSPREY Closed IV Catheter System (OspreyV2)
Skydance Vascular, Inc.
TriMed Threaded Intramedullary Nail System
TriMed, Inc.
JuggerKnot Soft Anchor
Riverpoint Medical, LLC
Optilume® High Pressure Urological Balloon Dilation Catheter
Urotronic, Inc.
iLet® ACE Pump
Beta Bionics, Inc.
Elation Pulmonary Balloon Dilation Catheter
Merit Medical Systems, Inc.
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