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

KGN 2016-06-23

Collagen Dental Wound Dressings

Applicant Collagen Matrix, Inc.

K-Number K152600

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NLH 2016-06-23

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter

Applicant Sterilmed, Inc.

K-Number K153006

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HCG 2016-06-22

Target Detachable Coils

Applicant Stryker Neurovascular

K-Number K161429

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HJO 2016-06-22

Portable Slit Lamp

Applicant Shanghai Bolan Optical-Electric Co., Ltd.

K-Number K153545

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LLZ 2016-06-22

IMPAX Volume Viewing 4.0

Applicant Agfa Healthcare N.V.

K-Number K161061

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DPS 2016-06-22

Portable ECG Monitor

Applicant Contec Medical Systems Co.,Ltd

K-Number K152863

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ERL 2016-06-22

PolypVac Microdebrider (3.3mm and 4.0mm)

Applicant Laurimed, LLC

K-Number K161101

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OBJ 2016-06-22

OptiCross 18, 30 MHz Peripheral Imaging Catheter

Applicant Boston Scientific Corporation

K-Number K160514

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JWY 2016-06-22

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

Applicant Liofilchem s.r.l.

K-Number K153569

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FLL 2016-06-22

CliniCloud Non-contact Thermometer, Model SPL1024

Applicant Stethocloud Pty.Ltd (Clinicloud)

K-Number K161325

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JXI 2016-06-22

NERBRIDGE

Applicant Toyobo Co., Ltd.

K-Number K152967

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KNT 2016-06-21

Aquarius Stoma Measuring Device

Applicant Degania Silicone , Ltd.

K-Number K152246

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