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

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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LYY 2023-02-22

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

Applicant Shandong Intco Medical Products Co, Ltd.

K-Number K223298

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HAW 2023-02-22

Disposable Pre-calibrated Brain Biopsy Needle 2.0

Applicant PAJUNK GmbH Medizintechnologie

K-Number K230201

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EFB 2023-02-22

TRAUS Air Dental Handpiece

Applicant Saeshin Precision Co., Ltd.

K-Number K221741

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