BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    X-CAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    HAEMONETICS MCS+ (LN8150) for RBC APHERESIS

    FDA UDI
    HAEMONETICS CORPORATION·10812747013482·TWO UNIT RED CELLS DISPOSABLE SETS

    Clear Readers

    FDA UDI
    Diversified Products, Inc.·00842894127810·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450419779·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0132000·Rod Reducer, Axial, NIDO

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702290851·ELVAREX 3/THIGH HIGH/PROFILE, CLOSED TOE, KNEE ...

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CERANUM 76

    FDA 510(k)
    FDA Class 2 ·Dental

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    CAPTIFLEX¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·April 29, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 11, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 13, 2011

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 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