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

NYO 2018-03-30

ImmuLisa Enhanced RNA POL III Antibody ELISA

Applicant Immco Diagnostics, Inc.

K-Number K172078

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PNR 2018-03-30

AMSure® Enteral Feeding Syringe with ENFit Tip

Applicant Amsino International, Inc.

K-Number K171857

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LNH 2018-03-30

MAGNETOM Vida with Compressed Sensing GRASP-VIBE

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173617

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JAK 2018-03-30

SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173630

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DYB 2018-03-30

Performer Guiding Sheath

Applicant Cook Incorporated

K-Number K171988

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LNH 2018-03-30

G-scan Brio

Applicant Esaote, S.p.A.

K-Number K180592

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NHA 2018-03-30

Straumann Variobase for Crown AS

Applicant Institut Straumann AG

K-Number K173379

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MSB 2018-03-30

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

Applicant Paragonix Technologies, Inc.

K-Number K180194

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FGB 2018-03-30

OLYMPUS URF-V2/V2R

Applicant Olympus Medical Systems Corp.

K-Number K172246

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DQY 2018-03-30

Merit Pursue Microcatheter

Applicant Merit Medical Systems, Inc.

K-Number K173548

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DZE 2018-03-30

UF(II) Implant System

Applicant Dio Corporation

K-Number K170608

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PKR 2018-03-30

gammaCore Sapphire

Applicant Electrocore, LLC

K-Number K180538

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