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

JAK 2025-07-28

NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

Applicant Siemens Medical Solutions USA, Inc.

K-Number K251061

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NHA 2025-07-28

ISO Abutment

Applicant Seum Medi Co., Ltd.

K-Number K241183

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FRN 2025-07-28

SIGMA Spectrum Infusion Pump with Master Drug Library

Applicant Baxter Healthcare Corporation

K-Number K251640

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NHA 2025-07-28

NUVENTUS NV.C Prosthetic Components

Applicant Infinitum Eta, Ltd.

K-Number K251220

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QLX 2025-07-28

Alinity m EBV (09N43-095)

Applicant Abbott Molecular, Inc.

K-Number K243489

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NUH 2025-07-28

3 in 1 TENS UNIT (TC1241, TC2241, TS1241)

Applicant Changsha Anxiang Medical Technology Co., Ltd.

K-Number K251187

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QYE 2025-07-28

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

Applicant Anumana, Inc.

K-Number K250652

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JAK 2025-07-25

Marie

Applicant Leo Cancer Care

K-Number K250970

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HRS 2025-07-25

A.L.P.S. Proximal Humerus Plating System

Applicant Zimmer Biomet

K-Number K251620

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IYN 2025-07-25

Venue; Venue Go; Venue Fit; Venue Sprint

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K251322

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FOZ 2025-07-25

BD Nexiva Closed IV Catheter System

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K243403

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KRH 2025-07-25

TransForm McCarthy Mitral Annuloplasty Ring (TF)

Applicant Genesee Biomedical, Inc.

K-Number K250859

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