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

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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EIH 2016-01-14

Rainbow LS Pressing

Applicant Genoss

K-Number K151846

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MLR 2016-01-13

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

Applicant Advanced Sterilization Products

K-Number K151725

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DQO 2016-01-13

IntraNovo Microcatheter

Applicant Texasmedical Technologies, Inc.

K-Number K153125

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NHA 2016-01-13

BioHorizons CAD/CAM Abutments

Applicant BioHorizons Implant Systems, Inc.

K-Number K151621

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