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

QQX 2022-09-13

Simplexa COVID-19 Direct

Applicant Diasorin Molecular, LLC

K-Number K212147

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LZO 2022-09-13

SP-CL Hip Stem and LCU Hip System

Applicant Waldemar Link GmbH & Co. KG

K-Number K213770

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KGO 2022-09-13

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves

Applicant Guilin Hbm Health Protections, Inc.

K-Number K221748

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NUH 2022-09-13

Transcutaneous Electrical Nerve Stimulator Model: ST-304

Applicant Shenzhen Future Electronic Co., Ltd.

K-Number K221092

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GCJ 2022-09-12

Plasma Shield

Applicant Plasmatica, Ltd.

K-Number K221533

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JAK 2022-09-12

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

Applicant Canon Medical Systems Corporation

K-Number K220986

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OUR 2022-09-12

Integrity-SI Fusion System

Applicant OsteoCentric Technologies

K-Number K222512

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KLE 2022-09-12

Phosphoric Acid Etching Gel

Applicant Rizhao Huge Biomaterials Company, Ltd.

K-Number K221450

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IYN 2022-09-12

KOLO Evolution XHD Series Ultrasound Diagnostic System

Applicant Kolo Medical (Suzhou) Co., Ltd.

K-Number K221568

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DQY 2022-09-12

SOFIA 88 Catheter

Applicant MicroVention, Inc.

K-Number K214024

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QAS 2022-09-12

Rapid ICH

Applicant Ischemaview, Inc.

K-Number K221456

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FLL 2022-09-12

Infrared Forehead Thermometer

Applicant Qingdao Yasee Medical Device Co., Ltd.

K-Number K220084

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