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

HAE 2020-07-21

Ace Medical Surgical Instruments

Applicant Ace Medical

K-Number K200387

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PNN 2020-07-21

AUTOLIGN

Applicant Diorco Co., Ltd.

K-Number K192847

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DQY 2020-07-21

BOBBY Balloon Guide Catheter

Applicant MicroVention, Inc.

K-Number K193607

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DQX 2020-07-21

Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire

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

K-Number K201690

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KCT 2020-07-20

Benesta Medical Sterilization Tray

Applicant Caldera Medical, Inc.

K-Number K193603

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MIB 2020-07-20

BioSiCar Silicone Implant

Applicant Metalware Technology Corp.

K-Number K193392

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DQA 2020-07-20

GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable

Applicant Covidien, LLC

K-Number K201179

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MEG 2020-07-20

Retractable Safety Insulin Syringe

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K193022

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CAW 2020-07-20

Owgels Oxygen Concentrator

Applicant Guangzhou Life Light Electronic Technology Co., Ltd.

K-Number K191875

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HRX 2020-07-20

Smith+Nephew Arthroscopes

Applicant Smith & Nephew

K-Number K201349

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FPA 2020-07-20

Intravascular Extension Sets and Accessories

Applicant Baxter Healthcare Corporation

K-Number K192366

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NRY 2020-07-20

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set

Applicant Codman & Shurtleff, Inc.

K-Number K193380

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