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

KWQ 2023-05-09

ATEC Lateral Plate System

Applicant Alphatec Spine, Inc.

K-Number K230721

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NUC 2023-05-08

JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114

Applicant CC Wellness, LLC

K-Number K230674

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GDW 2023-05-08

Anika Tissue Tack Fixation System

Applicant Anika Therapeutics, Inc.

K-Number K222487

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PGY 2023-05-08

MX50N

Applicant Wide Corporation

K-Number K222716

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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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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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