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

DQA 2024-05-20

AViTA Pulse Oximeter

Applicant Avita Corporation

K-Number K223399

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ETD 2024-05-20

Solo+ Tympanostomy Tube Device (TTD)

Applicant Aventamed Dac

K-Number K232702

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BTR 2024-05-20

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

Applicant Covidien, LLC

K-Number K233341

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LYZ 2024-05-20

Disposable Vinyl Examination Gloves

Applicant Anqing Pukang Medical Technology Co., Ltd.

K-Number K241252

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GEX 2024-05-20

Multi-function Platform Systems (BL-M10)

Applicant Shanghai Bele Medical Technology Co.,Ltd

K-Number K240474

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DXE 2024-05-20

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

Applicant Edwards Lifesciences

K-Number K233619

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KWQ 2024-05-17

MiRus MoRe Lumbar Plating System

Applicant MiRus, LLC

K-Number K241175

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FRN 2024-05-17

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets

Applicant Zevex, Inc.

K-Number K232793

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KWQ 2024-05-17

ARENAL Anterior Cervical Plate System

Applicant Effortmed, LLC

K-Number K240935

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QUQ 2024-05-17

Kahook Dual Blade Glide (KDB Glide)

Applicant New World Medical, Inc.

K-Number K220891

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HHW 2024-05-17

Yoni.Fit Bladder Support

Applicant Watkins-Conti Products, Inc.

K-Number K232525

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KWQ 2024-05-17

icotec Anterior Cervical Plate System

Applicant Icotec AG

K-Number K233215

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