BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018

    CARTO XP EP NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·September 27, 2024

    VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·October 2, 2024

    HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FMJ·February 19, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 12, 2011

    M SERIES

    FDA Adverse Event
    Death ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 11, 2008

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    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 Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015