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

PCC 2024-06-03

Milieve (YPS-301BD)

Applicant Soterix Medical, Inc.

K-Number K233751

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FQO 2024-06-03

Maestro System (REF100)

Applicant Moon Surgical

K-Number K240598

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HTN 2024-06-03

TENSOR® Suture Button System

Applicant Globus Medical, Inc.

K-Number K240947

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PKL 2024-06-03

Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)

Applicant Olympus Medical Systems Corp.

K-Number K240617

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MMX 2024-06-03

Amplatz Goose Neck Snare Kit

Applicant Medtronic, Inc.

K-Number K241259

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KDI 2024-05-31

multiFlux 1000 (F00012408)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K240394

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QFM 2024-05-31

CINA-VCF

Applicant Avicenna.Ai

K-Number K240612

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OBP 2024-05-31

Deep TMS System

Applicant Brainsway , Ltd.

K-Number K222196

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FRO 2024-05-31

Anti-bacterial bandage

Applicant Jinhua Jingdi Medical Supplies Co., Ltd.

K-Number K232333

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LLZ 2024-05-31

Bone Suppression Software

Applicant Konica Minolta, Inc.

K-Number K240281

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QYT 2024-05-31

iHealth COVID-19 Antigen Rapid Test

Applicant Ihealth Labs, Inc.

K-Number K233842

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LGZ 2024-05-31

°M Warmer System

Applicant Mequ A/S

K-Number K232107

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