BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814794·GENUMEDI EXTRA WIDE SILVER SIZE VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814749·GENUMEDI EXTRA WIDE SAND SIZE VI

    AGXO

    FDA UDI
    Oticon A/S·05707131165169·K130, BTE 13 P STG AGXO

    M2A 38MM

    FDA UDI
    Biomet Uk Ltd·05019279908714·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450174913·

    POLARUS CAP SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    LCD TOUCHSCREEN, RP150, S5

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 9, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    AGA MEDICAL CORPORATION·Product code MLV·May 26, 2011

    SORIN C5 SYSTEM

    FDA Adverse Event
    LIVANOVA DEUTSCHLAND·Product code DTQ·July 7, 2016

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·October 3, 2016

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·August 26, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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