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

OVE 2017-06-15

SeaSpine Shoreline ACS - Anterior Cervical Standalone System

Applicant SeaSpine Orthopedics Corporation

K-Number K170569

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FPA 2017-06-15

Encore Neutral

Applicant Rymed Technologies, LLC

K-Number K162826

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GAM 2017-06-15

TroClose1200, TroClose1200 Cannula

Applicant Gordian Surgical, Ltd.

K-Number K171494

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KGO 2017-06-15

Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)

Applicant Cardinal Health, Inc.

K-Number K170198

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PAY 2017-06-15

sensiLift

Applicant El Global Trade, Ltd.

K-Number K170499

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DXT 2017-06-15

Merit Coronary Control Syringe

Applicant Merit Medical Systems, Inc.

K-Number K163084

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NEU 2017-06-15

HydroMARK Breast Biopsy Site Markers

Applicant Devicor Medical Products, Inc.

K-Number K170803

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GZL 2017-06-15

AccuPoint Electrode

Applicant Microprobes For Life Science, Inc. Dba Neuron

K-Number K162459

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GEX 2017-06-15

Alma Q

Applicant Alma Lasers , Ltd.

K-Number K170850

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NDP 2017-06-15

SIMPLANT Guide

Applicant Dentsply Sirona

K-Number K170849

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KGN 2017-06-14

Endoform Topical Matrix

Applicant Aroa Biosurgery

K-Number K171231

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DJG 2017-06-14

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators

Applicant Immunalysis Corporation

K-Number K161216

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