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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

Fibresolve (with PCCP)

Imvaria, Inc.

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

Efofex, Inc.

FLUME catheter

The Flume Catheter Company, Ltd.

BD Vacutainer® K2 EDTA Blood Collection Tubes

Becton, Dickinson and Company

I.V. Administration Set, I.V. Extension Set

Bq Plus Medical Co., Ltd.

Keikku Electronic stethoscope

Lapsi Health Holding B.V.

uWS-Angio Pro

Shanghai United Imaging Healthcare Co., Ltd.

aprevo® anterior lumbar interbody fusion device with interfixation

Carlsmed, Inc.

Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-0

Jiangsu Bangbang Intelligent Technology Co., Ltd.

Collagen Dura Regeneration Membrane - Repair

Collagen Matrix, Inc.

INSULCLOCK® v2.0 PRO

Insulcloud S.L.

S.I.N. Dental Implant System

S.I.N. Implant System Ltda

VyLink™ Spinal Screw System

Vy Spine, LLC

G Surgical Marksman MIS System

G Surgical, LLC

Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multic

Techno-Path Manufacturing , Ltd.

ANDORATE® Valve Kit

Ga Health Company Limited

BruxZir™ Incisal Coloring Liquid

Prismatik Dentalcraft, Inc.

Diode Laser Therapy Systems (DL612A)

Hebei Zollvan Medical Technology Co., Ltd.

Tranquil-C Interbody System

Nexus Spine, LLC

Trivicta™ Hip Stem

Ortho Development Corp.

Advanced Cryo Wart Remover

Medical Brands Laboratories B.V.

AC Cream - Conductive paste

Spes Medica Srl

Sol-M Luer Lock Syringe

Sol-Millennium Medical, Inc.

Air Compression Massager (Model LF-FT003)

Wenzhou Lingfeng Electronic Technology Co., Ltd.

TMC Implant Fixation System

Treace Medical Concepts, Inc.

Terran NM-101

Terran Biosciences, Inc.

myray ProXIma X6

Cefla S.C.

Nd:Yag Laser Therapy Systems

Beijing Unt Technology Co., Ltd.

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula

Medline Industries, LP

AccuMeasure System

RQMIS, Inc.

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