BEUDAMED
    13 results · 31ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    COLLOSS E BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821051047·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

    GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MARY HITCHCOCK HANOVER NH 1

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·November 7, 2012

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    MIC-KEY LOW PROFILE GASTROSTOMY FEEDING TUBE

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK HEALTH CARE·Product code KNT·April 10, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·May 22, 2008

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·April 4, 2011

    EASYLINK

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JQP·November 25, 2014

    EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 23, 2010

    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