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

MVL 2020-10-15

STATSTIX

Applicant Centrix Incorporated

K-Number K200764

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KPS 2020-10-15

Cartesion Prime, PCD-1000A, V10.7

Applicant Canon Medical Systems Corporation

K-Number K202349

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IYN 2020-10-15

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K202683

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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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