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

HRS 2025-08-16

OsteoCentric® UnifiMI® TCS Plating System

Applicant OsteoCentric Technologies

K-Number K251913

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FIE 2025-08-15

JMS CAVEO A.V. Fistula Needle Set

Applicant JMS North America Corporation

K-Number K251877

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NFT 2025-08-15

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

Applicant Assure Tech., LLC

K-Number K252259

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GZJ 2025-08-15

CP Relief Wand Rx - TENS/NMES

Applicant N & C Holdings, LLC

K-Number K252236

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OHS 2025-08-15

FEATHER 01 02 03 04 (Model:01)

Applicant Heat IN A Click, LLC

K-Number K251871

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KPS 2025-08-15

PHAROS

Applicant Brightonix Imaging

K-Number K250170

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HRS 2025-08-15

KLS Martin Ixos System

Applicant KLS Martin L.P.

K-Number K250620

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QIH 2025-08-15

VEA Align; spineEOS

Applicant Eos Imaging

K-Number K251747

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HWC 2025-08-15

Dunamis Screw and Suture Locking System

Applicant Dunamis Medical, LLC

K-Number K250867

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DSH 2025-08-15

Zio® monitor (DFG0001)

Applicant iRhythm Technologies, Inc.

K-Number K243650

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DJG 2025-08-15

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

Applicant Healgen Scientific,, LLC

K-Number K251972

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HSX 2025-08-15

Persona Partial Knee

Applicant Zimmer Biomet

K-Number K251834

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