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

DQA 2023-03-08

Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K220101

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IMI 2023-03-08

ManaSport+

Applicant Manamed, Inc.

K-Number K222098

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BZQ 2023-03-08

Respiree Cardio-Respiratory Monitor

Applicant Respiree Pte, Ltd.

K-Number K223681

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EBF 2023-03-08

Dental Ceramic Blocks

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K223742

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OLO 2023-03-08

PathKeeper System

Applicant Pathkeeper Surgical , Ltd.

K-Number K222355

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KWQ 2023-03-07

Athena III Cervical Plate System

Applicant Medyssey USA, Inc.

K-Number K230301

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NEW 2023-03-07

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014

Applicant Hans Biomed Corporation

K-Number K220549

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QEP 2023-03-07

Visby Medical Sexual Health Test

Applicant Visby Medical

K-Number K220407

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QEB 2023-03-07

Enlight 2100

Applicant Timpel S.A.

K-Number K222897

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NUC 2023-03-07

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine

Applicant Rb Health (Us), LLC

K-Number K213892

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HRS 2023-03-07

Tyber Medical Anatomical Plating System

Applicant Tyber Medical, LLC

K-Number K222465

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JAK 2023-03-07

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

Applicant Canon Medical Systems Corporation

K-Number K223726

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