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

EMA 2022-08-30

Riva Cem Automix

Applicant Sdi Limited

K-Number K214118

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FRN 2022-08-30

Novum IQ Syringe Pump

Applicant Baxter Healthcare Corporation

K-Number K211125

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NFT 2022-08-30

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

Applicant Healstone Biotech, Inc.

K-Number K221871

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FMF 2022-08-30

Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use

Applicant Jiangsu Jichun Medical Devices Co., Ltd.

K-Number K212846

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QRL 2022-08-30

Lancing device

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K221970

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MUI 2022-08-30

Ultrasound Transmission Gels

Applicant Hony Medical Co., Ltd.

K-Number K221999

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DRB 2022-08-30

Arrow Stiffening Stylet

Applicant Arrow International, LLC (A subsidiary of Teleflex, Inc.)

K-Number K220280

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QTT 2022-08-30

SaliPen

Applicant Saliwell , Ltd.

K-Number K220618

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PHC 2022-08-30

Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K-Number K211124

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JKA 2022-08-30

SOL-GUARD Safety Pull Button Collection Set

Applicant Sol-Millennium Medical, Inc.

K-Number K213718

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FXX 2022-08-30

Medical Surgery Mask, Model:2626-7

Applicant Dongguan Missadola Technology Co., Ltd.

K-Number K220067

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DXN 2022-08-30

INDEX BPM

Applicant Ya Horng Electronic Co., Ltd.

K-Number K221486

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