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

EBW 2022-11-21

Implanter incl. Accessories

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K-Number K211358

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ODC 2022-11-21

Pentax Medical Valve Set

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K-Number K222980

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FPA 2022-11-21

Infusion Sets for Single Use

Applicant Sichuan Prius Biotechnology Co., Ltd.

K-Number K221075

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FPA 2022-11-21

Infusion Sets for Single Use with Needles

Applicant Sichuan Prius Biotechnology Co., Ltd.

K-Number K221069

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ONG 2022-11-21

SR-1 Skin Treatment System

Applicant AVAVA, Inc.

K-Number K221268

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HJO 2022-11-21

Kowa SL-19

Applicant Kowa Company , Ltd.

K-Number K222372

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IZL 2022-11-21

SM-V

Applicant Sedecal., Sa.

K-Number K222951

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KGN 2022-11-21

Miro3D Wound Matrix

Applicant Reprise Biomedical

K-Number K223257

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HSB 2022-11-21

Flex-Thread Ulna Intramedullary Nail System

Applicant Flower Orthopedics Corporation Dba Conventus Flower

K-Number K222390

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QRL 2022-11-21

Disposable Sterile Lancet

Applicant Tianjin Rilifine Medical Device Co., Ltd.

K-Number K222246

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LZA 2022-11-20

Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl

Applicant Sri Trang Gloves (Thailand) Public Company Limited

K-Number K221165

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DQA 2022-11-20

Empatica Health Monitoring Platform

Applicant Empatica S.r.l.

K-Number K221282

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