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

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    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112070·Tap, Cannulated, 5.5 mm

    LASER PERIPHERALS REUSABLE HOLMIUM FIBER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMPACT-PLUS

    FDA UDI
    Denplus Inc·D8451011207·IMPACT-PLUS, MDP, 2.3 kg

    ROLLO 112X25X12E/QT-HS/PRINTER (SIN FIN)

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763004813·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040014585·Zirlux 16+ A3.5 55x19x15

    CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 70 mm

    FDA UDI
    icotec AG·07640172553480·CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 ...

    TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTABLE INSTENSIVE CARE UNIT

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·October 21, 2011

    LUPINE DRILL BIT

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code GFG·May 13, 2011

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·March 14, 2019

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 19, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 14, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 11, 2007

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HWE·January 31, 2017

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019