BEUDAMED
    11 results · 28ms · 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 ×

    DIAGNOSTIC INTRASCULAR CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·February 21, 2020

    PT-MULTI-CALIBRATOR, MODEL OPAT07

    FDA 510(k)
    FDA Class 2 ·Hematology

    HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 12, 2020

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 24, 2020

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·January 2, 2013

    FOX SV PTA CATHETER

    FDA Adverse Event
    Malfunction ·AV-BERINGEN·Product code LIT·November 20, 2010

    NON-HEATED ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·June 30, 2014

    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 8, 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