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

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    NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125532·PowerChem Neoprene Exam Gloves, Medium

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 5, 2021

    VANGUARD REPROCESSED COMPRESSION GARMENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOVOFINE 31 DISPOSABLE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LINEAR 3-4

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 27, 2019

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014

    BD PRECISIONGLIDE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·April 10, 2013

    ACCURUS 400VS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 8, 2011

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013

    QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the STERIS SYSTEM I Processor and the C1160 Universal Flexible Processing Tray. The QFC1631 is for Fujinon 450/485 Series Video Gastroscopes; The QFC1683 is for Fujinon EC-450LP Colonoscopes; The QFC1685 is for Fujinon 450/485 Series Video Colonoscopes with Water Jet;

    FDA Recall
    Terminated ·Steris Corp·Product code MLR·March 20, 2003

    cobas 6000 analyzer series Operators Manual Roche cobas; 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

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015