BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    Disposable Blade

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50

    Disposable Blade

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50

    MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODULAR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    COOL-TIP

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 11, 2019

    COOL-TIP

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 11, 2019

    VENTRALEX ST

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·December 1, 2022

    SEPRAMESH IP

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·December 1, 2022

    VENTRALIGHT ST W/ECHO

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·December 1, 2022

    VENTRIO ST

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·December 1, 2022

    GYNECARE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTO·May 23, 2022

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code MIH·August 14, 2023

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·January 17, 2019

    TI LOW PROFILE SCREW 6.5X20MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·October 30, 2013

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021