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

NAY 2021-04-26

da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System

Applicant Intuitive Surgical, Inc.

K-Number K210918

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FXX 2021-04-26

Surgical Mask

Applicant Ningbo Green Textile Co., Ltd.

K-Number K202647

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GEI 2021-04-26

VIVACE Electrosurgical Device

Applicant ShenB Co., Ltd.

K-Number K193070

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GEX 2021-04-26

ERISE Laser handpiece

Applicant El.En Electronic Engineering Spa

K-Number K202258

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DZJ 2021-04-26

VSP System

Applicant 3D Systems

K-Number K210347

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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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QIH 2021-04-23

MEDO-Thyroid

Applicant Medo DX Pte. , Ltd.

K-Number K203502

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