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

LZA 2021-04-26

Powder Free Blue Nitrile Examination Glove

Applicant Vip Glove Sdn Bhd

K-Number K203512

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FAD 2021-04-26

Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System

Applicant Boston Scientific Corporation

K-Number K200260

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JOW 2021-04-23

Dayspring

Applicant Koya Medical, Inc.

K-Number K210885

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MUH 2021-04-23

PlutoX Digital Intraoral X-Ray Imaging System

Applicant Iray Technology Taicang , Ltd.

K-Number K210312

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OBP 2021-04-23

Brainsway Deep TMS System

Applicant Brainsway , Ltd.

K-Number K203735

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GEX 2021-04-23

Secret Duo

Applicant Ilooda Co,., Ltd.

K-Number K202043

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QOL 2021-04-23

Neurolutions Upper Extremity Rehabilitation System

Applicant Neurolutions, Inc.

K-Number DEN200046

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QIH 2021-04-23

MEDO-Thyroid

Applicant Medo DX Pte. , Ltd.

K-Number K203502

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FXX 2021-04-23

Medical Surgical Mask

Applicant Tianjin Aoshang Outdoor Equipment Co., Ltd.

K-Number K210030

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GEX 2021-04-23

Dermatological Diode Laser Systems

Applicant Zhuolu Jontelaser Manufacturing Technology Co., Ltd.

K-Number K202257

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FRO 2021-04-23

MIS Solution

Applicant Next Science, LLC

K-Number K203835

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FXX 2021-04-23

Disposable Surgical Face Mask

Applicant Guangdong Bida Medical Technology Co., Ltd.

K-Number K202387

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