BEUDAMED
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    SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    MODIFICATION TO FLOUROLAB PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    SELF SEAL STERILIZATION POUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SINAI HSP BALTIMORE MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

    LAKELAND REG LAKELAND FL 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

    WA ADVENT TAKOMA PARK MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    IOWA METH DES MOINES IA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

    LINOX SD 65/16

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·April 29, 2013

    CONSULTA CRT-D

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·May 10, 2011

    HS HAND CONTROLLED CURVED SHEA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GEI·July 23, 2008

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019

    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