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

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    VIS-U-ALL II SELF SEAL POUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526

    FDA 510(k)
    FDA Class 2 ·Hematology

    AVISTA MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 5, 2022

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 5, 2016

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 22, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 14, 2011

    LIFEPAK 9 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·July 3, 2008

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·May 1, 2014

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·April 28, 2014

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·March 27, 2014

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 13, 2015

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; 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