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

DPT 2016-05-12

moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager

Applicant Moor Instruments, Ltd.

K-Number K152749

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KGO 2016-05-12

Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)

Applicant Cardinal Health, Inc.

K-Number K153316

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JOW 2016-05-12

Venous Assist System

Applicant Daesung Maref Co., Ltd.

K-Number K150980

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FMK 2016-05-12

Genteel Lancing Device

Applicant Genteel, LLC

K-Number K153670

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KHJ 2016-05-11

Biodesign Otologic Repair Graft

Applicant Cook Biotech Incorporated

K-Number K161000

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EBG 2016-05-11

Vericore Gradient Temporary Disc

Applicant Whip Mix Corporation

K-Number K152443

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HJO 2016-05-11

Slit Lamp Microscope

Applicant Shanghai Mediworks Precision Instruments Co. , Ltd.

K-Number K152429

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KWT 2016-05-11

Catalyst CSR Shoulder System

Applicant Catalyst Orthoscience, LLC

K-Number K152825

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MBH 2016-05-10

Vanguard XP Knee System

Applicant Biomet, Inc.

K-Number K153657

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PMN 2016-05-10

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

Applicant Bio-Rad Laboratories

K-Number K152679

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MBI 2016-05-10

FiberTak DR

Applicant Arthrex, Inc.

K-Number K160319

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NLH 2016-05-10

Reprocessed Polaris X Steerable Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K160303

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