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.
    Filters Regulation: Us FDA ×

    I-D GLIDE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RESTORE-PF VIC; RESTORE-PF VLC CAPSULE

    FDA 510(k)
    FDA Class 2 ·Dental

    PIPER

    FDA 510(k)
    FDA Class 2 ·Radiology

    CELL-DYN DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

    TRIATHLON PS X3 TIBIAL INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 10, 2013

    SCORPIOFLEX PS TIB INSERT

    FDA Adverse Event
    Other ·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·May 22, 2008

    UNIVERSAL TROCAR HANDLE, NO CANNULA

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·April 6, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 10, 2010

    CELL-DYN RUBY SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·November 10, 2023

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019

    16G X 1.16IN (1.7 X 30 MM) ANGIOCATH

    FDA Adverse Event
    Injury ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·October 30, 2019

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024