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

JXG 2017-11-14

Smart External Drain (SED) System

Applicant Aqueduct Critical Care, Inc.

K-Number K172759

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DZE 2017-11-14

Straumann PURE Ceramic Implants

Applicant Straumann USA, LLC (On Behalf of Institut Straumann Ag)

K-Number K171769

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IYO 2017-11-14

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)

Applicant Echosens

K-Number K173034

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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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