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

NUJ 2024-04-29

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K232511

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SBA 2024-04-29

Eversense AP CGM System

Applicant Senseonics, Incorporated

K-Number DEN230052

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GEI 2024-04-29

Volnewmer

Applicant Classys, Inc.

K-Number K240248

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JWH 2024-04-26

EMPOWR Revision Symmetric Knee Cones

Applicant Encore Medical, L.P. (Dba Enovis)

K-Number K240324

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JAK 2024-04-26

FCT iSTREAM Phase 1

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K233583

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LNH 2024-04-26

uMR Jupiter

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K233673

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SAN 2024-04-26

ASTar BC G- Kit and ASTar Instrument

Applicant Q-Linea AB

K-Number K221688

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ODE 2024-04-26

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories

Applicant Endogastric Solutions, Inc.

K-Number K240879

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OWB 2024-04-26

DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl

Applicant Canon, Inc.

K-Number K232298

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MBH 2024-04-26

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)

Applicant Zimmer, Inc.

K-Number K240299

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LDF 2024-04-26

TME Temporary Myocardial Electrode

Applicant Osypka AG

K-Number K232261

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EOQ 2024-04-26

BioStar Single Use Transbronchial Aspiration Needle

Applicant Broncus Medical, Inc.

K-Number K232038

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