Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

IZL 2025-07-29

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS

Applicant Prognosys Medical Systems Private Limited

K-Number K243473

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NAY 2025-07-29

da Vinci Surgical System, IS5000

Applicant Intuitive Surgical, Inc.

K-Number K250442

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DRT 2025-07-29

Sleepiz One+ (2.5)

Applicant Sleepiz AG

K-Number K251364

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FRN 2025-07-28

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

Applicant Baxter Healthcare Corporation

K-Number K251636

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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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