BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    SWIFT FX BELLA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 19, 2019

    MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VANTAGE TITAN 3T

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 22, 2020

    45 DEG ANGLE DRILL

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code HTW·October 28, 2019

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code ---·February 20, 2009

    PEDICLE PROBE - CURVED LUMBAR LENKE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code HXB·January 5, 2023

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 14, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    INTELECT MOBILE US

    FDA Adverse Event
    DJ ORTHOPEDICS DE MEXICO·Product code IMG·March 29, 2011

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·July 6, 2020

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021