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

GAT 2019-05-01

HS Fiber

Applicant Riverpoint Medical

K-Number K190817

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KWQ 2019-05-01

Boomerang™ Anterior Cervical Plate System

Applicant Choicespine, LP

K-Number K190227

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HQB 2019-05-01

Vitreq disposable laser probes, light fibers and Chandelier

Applicant VitreQ BV

K-Number K182646

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CCK 2019-05-01

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

Applicant GE Healthcare Finland Oy

K-Number K183394

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JWY 2019-05-01

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

Applicant Biomerieux S.A.

K-Number K190154

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MJN 2019-04-30

Eclipse 2L

Applicant Balt USA, LLC

K-Number K183045

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KNT 2019-04-30

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

Applicant Convatec Limited

K-Number K190114

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IYE 2019-04-30

TOTIM Patient Cushion Immobilization System

Applicant Essebi Medical Srl

K-Number K190894

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MUJ 2019-04-30

MRCAT Pelvis

Applicant Philips Medical Systems MR Finland

K-Number K182888

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KPE 2019-04-30

Additive Cap

Applicant International Medical Industries, Inc.

K-Number K190305

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OUR 2019-04-30

SambaScrew 3D SI Fusion System

Applicant Orthofix, Inc.

K-Number K183342

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PNR 2019-04-30

Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)

Applicant Neomed, Inc.

K-Number K183540

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