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

QGL 2023-02-12

SMILE

Applicant Nu Eyne Co., Ltd.

K-Number K213629

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IYN 2023-02-10

S90 Exp Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K222596

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MQL 2023-02-10

ARTSMedia In Vitro Culture Medium (AM-IVC Medium)

Applicant Artsmedia Denmark Aps

K-Number K220715

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OVD 2023-02-10

Pisces™-SA STANDALONE ALIF Interbody System

Applicant Osseus Fusion Systems

K-Number K223413

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LLZ 2023-02-10

MD.ai Viewer

Applicant Mdai, Inc.

K-Number K223425

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FYA 2023-02-10

SEJONG Surgical Gown Soft

Applicant Sejong Healthcare Co., Ltd.

K-Number K220435

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FLL 2023-02-10

Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)

Applicant Zhejiang Rongsheng Industrial Co., Ltd.

K-Number K220657

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GEX 2023-02-10

Eneka Pro

Applicant Termosalud

K-Number K223680

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LZA 2023-02-10

Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

Applicant Top Glove Medical (Thailand) Co., Ltd.

K-Number K222129

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FYC 2023-02-10

Disposable Isolation Gown

Applicant Nanning Tecbod Biological Technology Co., Ltd.

K-Number K223467

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PCT 2023-02-10

Pro-Tx Endorectal Balloon (PROT-25)

Applicant Dxtx Medical, Inc.

K-Number K223249

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EIH 2023-02-10

Glass Ceramics

Applicant Yilink (Tianjin) Biotechnology Co., Ltd.

K-Number K222513

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