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

QSM 2025-08-20

Remanufactured EndoWrist Cobra Grasper (420190)

Applicant Rebotix

K-Number K250417

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SCA 2025-08-20

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test

Applicant Wondfo USA Co, Ltd.

K-Number K251563

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IYN 2025-08-20

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K251481

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NDC 2025-08-20

T1D1

Applicant Comerge AG

K-Number K252104

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JWY 2025-08-20

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)

Applicant Liofilchem s.r.l.

K-Number K251580

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HSB 2025-08-20

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System

Applicant Stryker GmbH

K-Number K251400

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LTT 2025-08-20

MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)

Applicant Beckman Coulter, Inc.

K-Number K243804

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QIH 2025-08-20

Salix Coronary Plaque (V1.0.0)

Applicant Artrya Limited

K-Number K251837

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FGE 2025-08-20

EndoFixTissue Fixation System

Applicant Softac Medical Technologies

K-Number K251229

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NHA 2025-08-20

LOCATOR® Angled Abutment

Applicant Zest Anchors, LLC

K-Number K250721

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SFN 2025-08-20

Delphi-MD System

Applicant Quantalx Neuroscience, Ltd.

K-Number DEN250002

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QSM 2025-08-19

Remanufactured EndoWrist Long Tip Forceps (420048)

Applicant Rebotix

K-Number K250387

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