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

SFC 2025-06-12

APO-Easy Genotyping kit

Applicant Firalis SA

K-Number DEN240032

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MYN 2025-06-12

Second Opinion® CS

Applicant Pearl, Inc.

K-Number K243234

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FTL 2025-06-12

Bard® Mesh; Bard® Mesh Pre-Shaped

Applicant Davol, Inc.

K-Number K251557

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GCJ 2025-06-12

Medical Monitor (32HS710S)

Applicant Lg Electronics.Inc

K-Number K251209

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NKB 2025-06-12

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments

Applicant Ht Medical D.B.A. Xenix Medical

K-Number K251154

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GEX 2025-06-12

Deka Bluebeam

Applicant El.En S.P.A.

K-Number K243683

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HSB 2025-06-12

GMReis Fibula Nail System

Applicant Gm Dos Reis Industria E Comercio

K-Number K250559

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KPS 2025-06-12

Aurora

Applicant Ge Medical Systems Israel

K-Number K251153

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LSR 2025-06-12

iDart Lyme IgM ImmunoBlot Kit

Applicant Id-Fish Technology, Inc.

K-Number K242872

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KWL 2025-06-12

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

Applicant Biocomposites, Ltd.

K-Number K242865

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MAX 2025-06-12

FIX-L PEEK PLIF and T-PLIF System

Applicant Jeil Medical Corporation

K-Number K243973

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HRS 2025-06-11

LORRAINE 2.5/3.5mm Distal Humerus System

Applicant Bonebridge AG

K-Number K250933

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