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

LNH 2022-10-25

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K222968

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FXX 2022-10-25

Disposable Surgical Face Mask

Applicant Lyncmed Medical Technology (Beijing) Co., Ltd.

K-Number K212649

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LLZ 2022-10-25

3Dicom MD

Applicant Singular Health Pty, Ltd.

K-Number K222470

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FMK 2022-10-25

Unistik® Pro

Applicant Owen Mumford, Ltd.

K-Number K222303

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BWF 2022-10-25

Hudson RCI Triflo II Incentive Deep Breathing Exerciser

Applicant Medline Industries, Inc.

K-Number K220565

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LZA 2022-10-25

JR MEDIC Nitrile Examination Gloves Powder Free- Black

Applicant Jr Engineering & Medical Technologies (M) Sdn. Bhd.

K-Number K221169

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LRK 2022-10-24

Soft Palate Elevator

Applicant The Tmj Clinic PC

K-Number K222127

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FMK 2022-10-24

SafetiCET Safety Lancet

Applicant Nsp Tech Pte, Ltd.

K-Number K221783

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OVD 2022-10-24

MectaLIF Anterior Extension

Applicant Medacta International S.A.

K-Number K221545

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DQK 2022-10-24

KODEX EPD System 1.5.0

Applicant Philips Medical Systems Nederland, B.V. (Pmsn)

K-Number K212493

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OBT 2022-10-24

The GIRO Growth Modulation System

Applicant Pega Medical, Inc.

K-Number K220190

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OMC 2022-10-24

Neurosteer EEG Recorder

Applicant Neurosteer, Inc.

K-Number K221563

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