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

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    HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LATEX EXAMINATION GLOVE (POWDERED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 19, 2013

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC ORTHOPEDIC INC.·Product code KWP·December 4, 2009

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    ULTRA DRIVE 6MM PLUG PULLER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDX·July 20, 2022

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·December 4, 2009

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·May 29, 2013

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 8, 2013

    DUROM US ACETABULAR COMPONENT 48/42 H

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 25, 2011

    PULSE GEN MODEL 100

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 9, 2008

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    WARSAW ORTHOPEDIC, INC.·Product code KWP·August 26, 2011

    LINEAR 7.5 FR. 40CC IAB

    FDA Adverse Event
    Injury ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 14, 2020

    XP-CR Tibial Tray - Interlok 65mm Item # 195270

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013