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

KRH 2024-04-09

TransForm McCarthy Mitral Annuloplasty Ring (TF)

Applicant Genesee Biomedical, Inc.

K-Number K232599

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GCJ 2024-04-09

Disposable Trocars

Applicant Hangzhou Kangji Medical Instrument Co., Ltd.

K-Number K233263

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QBD 2024-04-08

Sample preservation solution

Applicant Zhejiang Gene Science Co., Ltd.

K-Number K212878

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NHJ 2024-04-08

BiWaze Clear System

Applicant Abmrc, LLC

K-Number K231728

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QAS 2024-04-08

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K240291

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KWQ 2024-04-08

TDM Anterior Cervical Plate System

Applicant Tdm Co., Ltd.

K-Number K240423

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LZA 2024-04-08

Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Yue Kang Anhui Medical Products Co., Ltd.

K-Number K240021

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PHX 2024-04-05

Catalyst F1x Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K234105

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SAR 2024-04-05

APPRAISE-HRI

Applicant The Surgeon General, Department of the Army (TSG-DA)

K-Number K233249

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NXC 2024-04-05

DigiLine Direct Print Aligner System

Applicant Park Dental Research Corporation

K-Number K233935

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FDS 2024-04-05

Ambu® aScope™ Gastro Large; Ambu® aBox™ 2

Applicant Ambu A/S

K-Number K232919

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EOQ 2024-04-05

LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)

Applicant MacroLux Medical Technology Co., Ltd.

K-Number K233779

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