BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X0616650·6mm H x 16mm W x 65mm L x 0 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X061665120·6mm H x 16mm W x 65mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X06166580·6mm H x 16mm W x 65mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L061665120·6mm H x 16mm W x 65mm L XLIF Trial 12 degree Lo...

    IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BCT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    CELL-DYN DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·September 25, 2024

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 28, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·September 4, 2014

    PLUS SL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC., ORTHOPAEDIC AG·Product code KWY·June 17, 2008

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024