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

DQX 2016-01-22

PW Guidewires

Applicant Tatara Vascular, LLC

K-Number K152497

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DQY 2016-01-22

ASAHI Caravel

Applicant Asahi Intecc Co., Ltd.

K-Number K152447

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OMP 2016-01-22

Mepiseal Soft Silicone Sealant

Applicant Molnlycke Health Care Us, LLC

K-Number K152741

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OQU 2016-01-22

SonarMed AirWave, Airway Monitoring System

Applicant Sonarmed, Inc.

K-Number K143042

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HCG 2016-01-22

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)

Applicant MicroVention, Inc.

K-Number K153594

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MAH 2016-01-22

Ponto Bone Anchored Hearing System

Applicant Oticon Medical AB

K-Number K152820

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NLH 2016-01-22

Livewire Electrophysiology Catheter

Applicant Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K-Number K151617

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GWM 2016-01-22

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

Applicant Medos International SARL

K-Number K152670

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EIA 2016-01-22

TAURUS C1

Applicant Shinhung Company, Ltd.

K-Number K151996

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LIT 2016-01-22

Crosperio RX PTA Balloon Dilatation Catheter

Applicant KANEKA Corporation

K-Number K152887

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GZJ 2016-01-22

FD TENS 2090, FD TENS 2095

Applicant Fuji Dynamics , Ltd.

K-Number K152676

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GCJ 2016-01-22

VersaOne Bladed Trocar 5mm

Applicant Covidien

K-Number K152149

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