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

NUH 2023-05-08

Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)

Applicant Shenzhen Leqing Medical Instrument Co., Ltd.

K-Number K223428

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LZA 2023-05-08

Disposible Nitrile Gloves

Applicant Holik Asia Group Co.,Ltd

K-Number K223280

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DQX 2023-05-05

Wattson temporary pacing guidewire (2250)

Applicant Vascular Solutions, LLC

K-Number K230637

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DXN 2023-05-05

Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683

Applicant Shenzhen Yuezhongxing Technology Co., Ltd.

K-Number K222926

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FOZ 2023-05-05

Polyguard and Polyshield Safety IV Catheters

Applicant Poly Medicure Limited

K-Number K230616

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OHS 2023-05-05

LED Facial Mask

Applicant Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.

K-Number K230351

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OLO 2023-05-05

Rod Registration Frame

Applicant Nu Vasive, Incorporated

K-Number K230989

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QVP 2023-05-05

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number DEN210040

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HQD 2023-05-05

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

Applicant Paragon Vision Sciences, Inc.

K-Number K221768

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EIA 2023-05-05

ELEC Master, ELEC Master Dual

Applicant Mgnewton , Ltd.

K-Number K202963

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INI 2023-05-05

Electric Scooter (Model: S3312)

Applicant Guangdong Prestige Technology Co., Ltd.

K-Number K230615

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EZN 2023-05-05

ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter

Applicant Allwin Medical Devices, Inc.

K-Number K220781

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