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

BSZ 2023-03-28

Carestation 750/750c

Applicant Datex-Ohmeda, Inc.

K-Number K213867

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PKL 2023-03-28

Disposable Endoscopic Hemoclip

Applicant Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K-Number K222146

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HIF 2023-03-28

Gas Insufflator

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K-Number K221995

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FXX 2023-03-27

Disposable Surgical Face Mask

Applicant Efofex, Inc.

K-Number K223823

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NEY 2023-03-27

Solero Microwave Tissue Ablation (MTA) System and Accessories

Applicant AngioDynamics, Inc.

K-Number K223581

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EIH 2023-03-27

XT Stain/Glaze

Applicant Shenzhen Xiangtong Co., Ltd.

K-Number K223192

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MTJ 2023-03-27

Meril-Bonewax

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K200452

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MYN 2023-03-27

Overjet Caries Assist

Applicant Overjet, Inc.

K-Number K222746

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EBD 2023-03-27

RODIN Palette Naturalizing Kit

Applicant Belport Company, Inc., Gingi-Pak

K-Number K223365

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FTC 2023-03-27

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)

Applicant Shenzhen Honpal Optoelectronic Technology Co., Ltd.

K-Number K223882

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LZA 2023-03-25

Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs

Applicant Yty Industry (Manjung) Sdn Bhd

K-Number K220644

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LYZ 2023-03-25

Vinyl examination gloves

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K230046

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