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

HTY 2019-01-25

HammerToe Compression System

Applicant Paragon 28, Inc.

K-Number K183228

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GKZ 2019-01-25

Sysmex XN-L Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K-Number K182389

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GJS 2019-01-25

microINR System

Applicant Iline Microsystems, S.L.

K-Number K180780

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KTT 2019-01-25

Hoffmann LRF System

Applicant Stryker GmbH

K-Number K182968

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JOW 2019-01-25

medi pneumatic compression system (pcs) – brio (Model 651)

Applicant Medi USA, LP

K-Number K183631

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HHW 2019-01-25

Revive Reusable Bladder Support

Applicant Rinovum Subsidiary 2, LLC

K-Number K183468

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OUR 2019-01-25

SI-Restore® Sacroiliac Joint Fixation System

Applicant Biofusion Medical

K-Number K182919

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KWS 2019-01-25

SMR Lateralized Connectors with screws

Applicant Lima Corporate S.P.A.

K-Number K183042

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PLK 2019-01-25

Earlens Contact Hearing Aid

Applicant Earlens Corporation

K-Number K182480

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PID 2019-01-25

Wilson-Cook Achalasia Balloon

Applicant Wilson-Cook Medical, Inc.

K-Number K182895

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HRS 2019-01-25

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K-Number K183321

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EIH 2019-01-25

GenesisZr™ 4Y Zirconia

Applicant United Dental Resources Corporation

K-Number K182642

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