BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    MASON EQUIPMENT ORGANIZER & ASPEN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AMES TDA ETHOSUXIMIDE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FRONT-LINE Field Sterilizer (FL135)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500

    FDA Adverse Event
    Injury ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·March 10, 2026

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 2, 2014

    PORTEX 8.0MM CUFFED TRACHEAL TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL MD, INC.·Product code BTR·October 25, 2012

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·September 22, 2010

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018