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

NPL 2017-10-30

Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed

Applicant Geistlich Pharma AG

K-Number K171643

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OLO 2017-10-30

Intellijoint HIP Generation 2B System

Applicant Intellijoint Surgical, Inc.

K-Number K171525

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PGX 2017-10-30

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

Applicant Luminex Corporation

K-Number K172402

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KWS 2017-10-30

AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert

Applicant Encore Medical L.P.

K-Number K172351

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JOJ 2017-10-30

AN85/AN86 EO Indicators

Applicant Andersen Sterilizers, Inc.

K-Number K170426

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OWB 2017-10-30

XIDF-AWS801, Angio Workstation, V7.0

Applicant Toshibamedical Systems Corporation

K-Number K172646

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NPM 2017-10-30

Anorganic Bone Mineral with Collagen in Delivery Applicator

Applicant Collagen Matrix, Inc.

K-Number K171008

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JWH 2017-10-30

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

Applicant Stryker Orthopaedics

K-Number K172326

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MQV 2017-10-30

Bi-Ostetic Bioactive Glass Foam

Applicant Berkeley Advanced Biomaterials

K-Number K170917

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MCW 2017-10-30

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

Applicant Avinger, Inc.

K-Number K172236

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DQD 2017-10-30

Stethee Pro

Applicant M3Dicine Pty , Ltd.

K-Number K172296

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PZJ 2017-10-27

VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody

Applicant Ventana Medical Systems

K-Number DEN170030

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