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

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    MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAD-5 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

    HOURGLASS

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQP·June 16, 2014

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033296·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...

    BIOMET SCK KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOSS MIAMI SPINAL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    R90 SPACERS

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MQP·October 9, 2009

    R90 SPACERS

    FDA Adverse Event
    Other ·WARSAW ORTHOPEDIC INC·Product code MAX·November 6, 2009

    R90 SPACERS

    FDA Adverse Event
    Injury ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·December 21, 2009

    TOTALCARE FRAME

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 1, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 30, 2011

    COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·April 22, 2008

    R90 SPACER

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code NKB·August 5, 2011

    C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 2016

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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