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

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    LIFEPAK 12 DEFIBRILLATOR/MONITOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108314·BARRAQUER NEEDLE HOLDER STRAIGHT

    TI-DBLE LEAD CORT SCR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSB·August 24, 2018

    ROUND FILTERS W/INDICATOR

    FDA Adverse Event
    Malfunction ·SPS MEDICAL·Product code FRG·February 28, 2014

    POINT 4 MODIFIED

    FDA 510(k)
    FDA Class 2 ·Dental

    INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

    FDA 510(k)
    FDA Class 2 ·Radiology

    REMB SAG SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·April 17, 2013

    AXSYM RUBELLA IGG ANTIBODY

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code LFX·June 19, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 19, 2011

    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