BEUDAMED
    20 results · 39ms · Sources: EU EUDAMED, US FDA

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    APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SINAI HSP BALTIMORE MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

    LAKELAND REG LAKELAND FL 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

    WA ADVENT TAKOMA PARK MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    IOWA METH DES MOINES IA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0430210·Sagittal Bender, Double Ended Right

    ZAVATION

    FDA UDI
    Zavation LLC·00842166156876·HA+ ALIF 8deg 30mmx21

    Zavation

    FDA UDI
    Zavation LLC·00842166106086·ALIF 8deg 30mmx21

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154650·WHITNEY 8deg 30mmx21mm

    Zavation

    FDA UDI
    Zavation LLC·00842166180321·ALIF Sizer 8deg 30mm x 21mm

    MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIGHTLANCE LASER SKIN PERFORATOR

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

    NA

    FDA UDI
    Hangzhou AGS MedTech Co., Ltd.·06959664929001·

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·April 29, 2013

    BARD-DAVOL

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code GCY·May 4, 2011

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 23, 2008

    CHLORAPREP ONE STEP HI LITE ORANGE

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KXF·August 30, 2020

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019

    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