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

DQY 2021-03-01

Recon Support Catheter

Applicant C.R. Bard, Inc.

K-Number K203275

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DQA 2021-03-01

Fingertip pulse oximeter

Applicant Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

K-Number K202776

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HGX 2021-03-01

imani i2

Applicant Imani Co.

K-Number K202037

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EBZ 2021-03-01

VALO Grand Corded and Accessory Lenses

Applicant Ultradent Products, Inc.

K-Number K210550

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POL 2021-03-01

Solitaire X Revascularization Device

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K203358

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DQA 2021-03-01

Med-Link Temp-pulse Oximeter

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K-Number K202743

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FLE 2021-03-01

Getinge GSS610N Series Steam Sterilizer

Applicant Maquet GmbH

K-Number K201927

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LZA 2021-03-01

Nitrile Examination Gloves (Blue, Violet Blue, White)

Applicant Jiangsu Tianshuo Medical Products Co., Ltd.

K-Number K202402

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KCT 2021-03-01

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

Applicant Avinent Implant System S.L.U.

K-Number K201533

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DSH 2021-02-28

QardioCore

Applicant Qardio, Inc.

K-Number K201644

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OLO 2021-02-26

Erisma LP Navigated Instruments

Applicant Clariance, Sas

K-Number K202956

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GEX 2021-02-26

Laser Treatment System, Model: NYX and Grace

Applicant Canadian Pioneer Medical Technology Corporation

K-Number K210033

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