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

HRS 2017-09-08

Footmotion Plating System

Applicant Newclip Technics

K-Number K171510

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LZA 2017-09-08

Powder Free Nitrile Examination Glove

Applicant Professional Latex Sdn Bhd

K-Number K171667

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GKR 2017-09-08

hemochroma PLUS System

Applicant Immunostics Inc.,

K-Number K163465

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EBC 2017-09-08

Nanova Sealant

Applicant Nanova Biomaterials, Inc.

K-Number K171330

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JOW 2017-09-08

Medline Hemo-Force DVT Compression Sleeve

Applicant Medline Industries, Inc.

K-Number K170415

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BSP 2017-09-08

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford

Applicant Spectra Medical Devices

K-Number K163292

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DTK 2017-09-08

ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook

Applicant Aln Implants Chirurgicaux

K-Number K163699

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GEX 2017-09-08

BM.IRIS

Applicant Bluecore Co., Ltd.

K-Number K171648

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GZT 2017-09-07

NICO BrainPath

Applicant Nico Corporation

K-Number K172433

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DQY 2017-09-07

XableCath Support Catheter

Applicant Xablecath, Inc.

K-Number K170041

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DZE 2017-09-07

Implantium II

Applicant Dentium Co., Ltd.

K-Number K171126

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HBE 2017-09-07

Cranial Drill Bits and Accessories

Applicant Ad-Tech Medical Instrument Corporation

K-Number K170442

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