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

QSZ 2024-07-05

SiOxD® Wound Matrix

Applicant Sioxmed, LLC

K-Number K241660

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MUH 2024-07-05

DUO1 and DUO2

Applicant Zinnovi, Inc.

K-Number K241649

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OLO 2024-07-05

Anatase Navi Disposable Instrument

Applicant Remex Medical Corp.

K-Number K241625

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MYE 2024-07-03

Gastric Alimetry

Applicant Alimetry , Ltd.

K-Number K240946

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DDG 2024-07-03

Access sTfR

Applicant Beckman Coulter, Inc.

K-Number K240987

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HWC 2024-07-03

OSSIOfiber® Threaded Trimmable Fixation Nail

Applicant OSSIO , Ltd.

K-Number K241277

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PLL 2024-07-03

Blue Eye

Applicant The Standard Co., Ltd.

K-Number K241591

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FET 2024-07-03

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

Applicant Olympus Medical Systems Corporation

K-Number K241371

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NLQ 2024-07-03

Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)

Applicant Stryker Sustainability Solutions

K-Number K241606

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GEX 2024-07-03

Dermablate

Applicant Asclepion Laser Technologies GmbH

K-Number K241600

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MBI 2024-07-03

Iconix® Anchor

Applicant Riverpoint Medical

K-Number K241577

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GAG 2024-07-03

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

Applicant Ethicon Endo-Surgery, LLC

K-Number K241629

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