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

LRC 2020-10-15

SINUSPRIME Dilation System

Applicant Stryker Ent

K-Number K201398

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GEX 2020-10-15

Opera Evo

Applicant Quanta System Spa

K-Number K202041

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DZE 2020-10-14

Z5-BL

Applicant Z-Systems AG

K-Number K200386

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ODP 2020-10-14

CONSTRUX Mini PTC Spacer System

Applicant Orthofix, Inc.

K-Number K202666

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BZG 2020-10-14

Spirotrac

Applicant Vitalograph Ireland, Ltd.

K-Number K201562

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DQX 2020-10-14

Merit Hydrophilic Guide Wire

Applicant Merit Medical Systems, Inc.

K-Number K201595

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NUC 2020-10-13

Astroglide Organix Liquid

Applicant Biofilm, Inc.

K-Number K200114

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PML 2020-10-13

G21 Cement, VADER® Pedicle System

Applicant Icotec AG

K-Number K200596

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HRS 2020-10-13

Skeletal Dynamics Ulnar Shortening Plating System

Applicant Skeletal Dynamics, Inc.

K-Number K201962

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MAX 2020-10-13

Zavation IBF System

Applicant Zavation Medical Products, LLC

K-Number K202305

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LZC 2020-10-11

Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove

Applicant 0 & M Halyard, Inc.

K-Number K200633

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JAK 2020-10-11

syngo.CT Neuro Perfusion

Applicant Siemens Medical Solutions USA, Inc.

K-Number K202213

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