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

HSB 2017-11-14

DePuy Synthes Femoral Recon Nail System

Applicant Synthes (USA) Products, LLC

K-Number K172157

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KRA 2017-11-13

CXI TriForce Peripheral Crossing Set

Applicant Cook Incorporated

K-Number K170931

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LZC 2017-11-13

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

Applicant Central Medicare Sdn Bhd

K-Number K172525

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EBF 2017-11-13

Pekkton Ivory

Applicant Cendres+Metaux SA

K-Number K170102

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KNW 2017-11-13

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)

Applicant Medax Srl Unipersonale

K-Number K172344

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GWO 2017-11-13

Stryker Universal Mesh

Applicant Stryker

K-Number K170725

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PQO 2017-11-13

Access AMH

Applicant Beckman Coulter, Inc.

K-Number K170524

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GXY 2017-11-13

Disposable Snap Electrode

Applicant Embla Systems

K-Number K172703

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HRS 2017-11-13

ANTHEM Fracture System

Applicant Globus Medical, Inc.

K-Number K173166

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MAX 2017-11-13

IMPIX 3D Print Cages

Applicant Medicrea International SA

K-Number K163595

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PZH 2017-11-11

A1AT Genotyping Test

Applicant Progenika Biopharma S.A., A Grifols Company

K-Number K171868

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HCI 2017-11-10

Aesculap Slim Clip Applier Forceps

Applicant Aesculap, Inc.

K-Number K173271

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