BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    PACS PLUS 5TH EDITION

    FDA 510(k)
    FDA Class 2 ·Radiology

    TEMP-BOND NE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUADRA BROACH SIZE 0

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·November 13, 2023

    BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2019

    MAXCEM ELITE CLEAR

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·April 29, 2013

    ACCENT DR RF

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 10, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 28, 2008

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·July 11, 2019

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 25, 2019

    QUADRA H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·January 14, 2011

    LINER: MPACT FLAT PE HC LINER 36/ER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 17, 2020

    MPACT LINER FLAT PE HC LINER Ø 32/D

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 5, 2016

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·December 13, 2023

    CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 17, 2022

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 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

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021