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

GCA 2021-04-27

Stone Retrieval Balloon Catheter

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K-Number K210660

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KNT 2021-04-27

Safety Trocar Cannula

Applicant Boston Scientific Corporation

K-Number K211072

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OAN 2021-04-27

STARband, STARlight, St. Louis Band

Applicant Orthomerica Products, Inc.

K-Number K203098

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DRT 2021-04-26

Vital Sign Monitoring Sensor (Model :XK300)

Applicant Xandar Kardian, Inc.

K-Number K202464

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GEX 2021-04-26

Dermatological Diode Laser Systems

Applicant Beijing HuaCheng Taike Technology Co., Ltd.

K-Number K210663

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NXC 2021-04-26

Illusion Aligners

Applicant Laxmi Dental Exports Pvt, Ltd.

K-Number K211010

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FMF 2021-04-26

MicroDose Injector

Applicant Medone Surgical, Inc.

K-Number K203264

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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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