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

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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KGO 2022-10-22

Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K222058

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QQX 2022-10-22

cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

Applicant Roche Molecular Systems, Inc.

K-Number K213804

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OHT 2022-10-21

Hair Removal Device (Model: IPL-D26, IPL-D19)

Applicant Shenzhen Desida Technology Co., Ltd.

K-Number K221643

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