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

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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LLZ 2019-04-30

XmaruView V1 (Xmaru Chiroview, Xmaru Podview)

Applicant Rayence Co., Ltd.

K-Number K190866

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DTE 2019-04-30

Medtronic Model 5392 External Pulse Generator (EPG)

Applicant Medtronic, Inc.

K-Number K190825

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PHC 2019-04-30

BD Intelliport System

Applicant Becton, Dickinson and Company

K-Number K182092

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PNL 2019-04-29

Magnetic Surgical System

Applicant Levita Magnetics International Corp

K-Number K190006

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