BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    IOB Temperature Management System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWP·October 10, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 11, 2013

    PROWLER SELECT MICROCATHETERS

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code KRA·July 14, 2011

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022