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
Aevumed RAPID Suture Anchors
Aevumed, Inc.
MD Mattress Suture Placement Device
Lsi Solutions, Inc.
Delta4 Insight
Scandidos AB
Fine Osteotomy
Bodycad Laboratories, Inc.
Disposable Blood Lancet
SteriLance Medical (Suzhou), Inc.
3D-RD-S
Radiopharmaceutical Imaging & Dosimetry, LLC
Monaco RTP System
Elekta Solutions AB
Synapse PACS (7.6.0)
FUJIFILM Healthcare Americas Corporation
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
Artivion, Inc.
VisionAir Enhanced Stock Stent
VisionAir Solutions
Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
Guangzhou Decheng Biotechnology Co., Ltd.
XLase Plus
Biotec Italia, Srl
Well-Life Incontinence Stimulation System (WL-2405i(P))
Well-Life Healthcare , Ltd.
Safety Lancet
Ningbo Medsun Medical Co., Ltd.
PathLoc SI Joint Fusion System
L&K BIOMED Co., Ltd.
AETOS Shoulder System Stemless Humeral Prosthesis
Smith & Nephew, Inc.
Smart Scope® CX
Periwinkle Technologies Pvt., Ltd.
OR3O Dual Mobility System
Smith & Nephew, Inc.
Millipede System
Perfuze, Ltd.
LED Facial Mask
Shenzhen Osto Technology Company Limited
Protable Phlegm Suction Unit (JMA D01)
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphe
Edwards Lifesciences, LLC
HyperVue Software
Spectrawave, Inc.
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42
Zdeer Technology (Henan) Co., Ltd.
Temporis, Irix Plus
Dws S.R.L.
AVIEW
Coreline Soft Co., Ltd.
MAVERICK Mini External Fixation System
Smith & Nephew, Inc.
Anivia SG1000 Pump Console
Apmtd, Inc.
VicorderCS (VCS-SYS-1100)
80 Beats Medical GmbH
T3 Pro Implants
Biomet 3i, LLC
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