BEUDAMED
    21 results · 32ms · Sources: EU EUDAMED, US FDA

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    PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 8, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010

    SYNCHRO-14 STRAIGHT 200-35CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 12, 2023

    SYNCHRO-10 STRAIGHT 200CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·October 13, 2023

    SYNCHRO-14 STRAIGHT 200-35CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·November 13, 2023

    SlimLine®

    FDA UDI
    ZIMMER SPINE, INC.·00889024403949·

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20321461·BioTorque wires Straight-Arch-F. mand. .018"x.025"

    KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EXETER V40(TM). RASP HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·April 3, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 28, 2011

    ENDEAVOR RX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·April 21, 2008

    ISODUR PROSTHESIS HEAD 12/14 32MM XL

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·August 10, 2022

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    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

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014