BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CETRA

    FDA UDI
    Orthofix US LLC·18257200120659·4-LEVEL PLATE ASSEMBLY, 66MM

    VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIGITAL RETINAL CAMERA, CR-1 MARK II

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    INTERSTIM

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code EZW·June 26, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024