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

FYA 2023-02-23

Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3

Applicant Stringking

K-Number K221559

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OHS 2023-02-23

LED light therapy mask (FM-01, FM-02, FM-03)

Applicant Guangdong Newdermo Biotech Co., Ltd.

K-Number K223544

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GEX 2023-02-22

The Alma Soprano Titanium

Applicant Alma Lasers, Inc.

K-Number K230371

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IYX 2023-02-22

3D-RD-S

Applicant Radiopharmaceutical Imaging and Dosimetry, LLC

K-Number K212587

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GAG 2023-02-22

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)

Applicant Covidien

K-Number K221629

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JXL 2023-02-22

PATI (Protector Against Tongue Injury)

Applicant Neurovice, LLC

K-Number K221469

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LNH 2023-02-22

Swoop® Portable MR Imaging System™

Applicant Hyperfine, Inc.

K-Number K230208

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LNS 2023-02-22

Delta III Pro

Applicant Dornier Medtech America, Inc.

K-Number K221903

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OLO 2023-02-22

Rosa Knee System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K230180

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QIH 2023-02-22

BoneMRI v1.6

Applicant Mriguidance B.V.

K-Number K230197

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HKI 2023-02-22

Eyer Retinal Camera NM-STD

Applicant Phelcom Technologies

K-Number K221329

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INI 2023-02-22

eFOLDi Scooter, Lite

Applicant Suntech UK , Ltd.

K-Number K223492

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