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

OXF 2017-02-10

GORE BIO-A Tissue Reinforcement

Applicant W. L. Gore & Associates, Inc.

K-Number K163217

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JDR 2017-02-10

EasyClip Xpress

Applicant Restore Surgical, LLC Dba Instratek

K-Number K162321

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KWS 2017-02-10

Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal

Applicant Custom Orthopaedic Solutions, Inc.

K-Number K162697

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NUC 2017-02-10

Astroglide Diamond Silicone Gel Personal Lubricant

Applicant Biofilm, Inc.

K-Number K163395

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JJW 2017-02-09

UA-Cellular Complete

Applicant Streck

K-Number K170091

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GDW 2017-02-09

Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

Applicant Tgs Medical Co., Ltd.

K-Number K162710

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MUJ 2017-02-09

Pinnacle Radiation Therapy Planning System

Applicant Philips Medical Systems (Cleveland), Inc.

K-Number K170086

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OBJ 2017-02-09

AcuNav Volume ICE Catheter

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163478

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NPM 2017-02-09

Porcine Anorganic Bone Mineral in Delivery Applicator

Applicant Collagen Matrix, Inc.

K-Number K162158

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MDB 2017-02-09

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Applicant Becton Dickinson

K-Number K161810

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HRS 2017-02-09

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long

Applicant DePuy Synthes

K-Number K163046

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NKB 2017-02-09

Hubble I System

Applicant Orbbo Surgical, LLC

K-Number K163566

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