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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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