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

FMZ 2017-06-23

Babyleo TN500

Applicant Draegerwerk AG & CO Kgaa

K-Number K162821

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PVZ 2017-06-23

hypodermic Pinpoint™ GT Needle

Applicant C.R. Bard, Inc.

K-Number K163437

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OYE 2017-06-23

Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser

Applicant Beckman Coulter

K-Number K162897

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LLZ 2017-06-23

SUITESTENSA

Applicant Ebit Srl

K-Number K163668

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KTI 2017-06-23

CRE Pulmonary Balloon Dilatation Catheter

Applicant Boston Scientific Corporation

K-Number K170759

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MQV 2017-06-23

ReBOSSIS85

Applicant Orthorebirth Co., Ltd.

K-Number K170620

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LGD 2017-06-23

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

Applicant Roche Diagnostics

K-Number K162678

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DRG 2017-06-23

Ossler Exam Scope

Applicant Lr Med, Inc.

K-Number K171188

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HQF 2017-06-23

YELLOW LASER PHOTOCOAGULATOR YLC-500

Applicant Nidek Co., Ltd.

K-Number K170302

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LYY 2017-06-23

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED

Applicant Vietglove Corporation

K-Number K170094

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DQY 2017-06-23

Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.

Applicant Arrow International, Inc. (Subsidiary of Telelflex Inc.)

K-Number K171146

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FRO 2017-06-23

Cerdak Basic

Applicant Bu Polysciences Equipment & Trading, LLC

K-Number K153138

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