Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

KWQ 2016-11-28

AccuFit Lateral Plate System

Applicant Precision Spine, Inc.

K-Number K162211

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KRA 2016-11-28

VAMP Venous/Arterial Blood Management Protection System

Applicant Edwards Lifesciences, LLC

K-Number K161962

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EBF 2016-11-28

Filtek One Bulk Fill Restorative

Applicant 3M Company

K-Number K163207

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DYW 2016-11-28

Carriere Motion Clear Class II

Applicant Ortho Organizers, Inc.

K-Number K160720

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DXQ 2016-11-28

Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K-Number K160530

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PGI 2016-11-28

Solana HSV 1+2/VZV Assay

Applicant Quidel Corporation

K-Number K162451

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LZA 2016-11-28

Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink

Applicant Terang Nusa Sdn Bhd

K-Number K161932

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LPN 2016-11-25

NNR06 Multi-Purpose Solution

Applicant Bausch & Lomb, Incorporated

K-Number K161819

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LNH 2016-11-25

Vantage Galan 3T, MRT-3020, V4.0

Applicant Toshibamedical Systems Corporation

K-Number K162183

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GAP 2016-11-23

SILK Surgical Suture

Applicant Teleflexmedical, Inc.

K-Number K162396

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KWS 2016-11-23

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)

Applicant Stryker GmbH

K-Number K161863

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HSB 2016-11-23

TRIGEN Low Profile Bone Screws

Applicant Smith & Nephew, Inc.

K-Number K161264

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