BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEPUY CMW 1G 40G

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LOD·October 5, 2023

    SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MAXIM PS TIB. BEARING

    FDA Adverse Event
    Injury ·BIOMET, INC.·Product code JWH·June 7, 2001

    BIOMET ARCOM AP PATELLA

    FDA Adverse Event
    Injury ·BIOMET, INC.·Product code HTG·June 7, 2001

    BIPOLAR ENDOCARDIAL LEAD

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS·Product code DTB·September 8, 1997

    UNK CEMENT CMW

    FDA Adverse Event
    Injury ·DEPUY CMW - 9610921·Product code LOD·December 21, 2020

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·April 22, 2013

    ADVANTAGE SERIES 29

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 19, 2011

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    ZIMMER SKIN GRAFT MESHER

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code FZW·March 21, 2014

    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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022