Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

HRS 2016-01-14

ARIX Wrist System

Applicant Jeil Medical Corporation

K-Number K151468

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PHX 2016-01-14

Aequalis Fx2

Applicant Tornier S.A.S.

K-Number K152966

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LKN 2016-01-14

Spectra Optia Apheresis System

Applicant Terumobct, Inc.

K-Number K153601

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PGD 2016-01-14

PillCam COLON 2 Capsule Endoscopy System

Applicant Given Imaging , Ltd.

K-Number K153466

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OQY 2016-01-14

ebb Complete Tamponade System

Applicant Clinical Innovations, LLC

K-Number K153591

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MPN 2016-01-14

GluStitch Twist Tissue Adhesive

Applicant Glustitch, Inc.

K-Number K150032

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CFR 2016-01-14

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method

Applicant Diatron U.S., Inc.

K-Number K151487

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MAX 2016-01-14

FORZA PTC Spacer System

Applicant Orthofix, Inc.

K-Number K152475

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OVE 2016-01-14

Amendia Stand-Alone Cervical System

Applicant Amendia, Inc.

K-Number K152972

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HWC 2016-01-14

Tiger Cannulated Screw System

Applicant Trilliant Surgical, Ltd.

K-Number K153338

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LIT 2016-01-14

Cronus HP - High Pressure Peripheral Balloon Catheter

Applicant Nipro Medical Corporation

K-Number K151141

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NHA 2016-01-14

ATLANTIS Abutment for NobelActive 3.0

Applicant Dentsply International, Inc.

K-Number K151039

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