BEUDAMED
    19 results · 32ms · Sources: EU EUDAMED, US FDA

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    KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DERMACLEAR UV-B PHOTOTHERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VERTE-STACK K030736, K041197

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019

    MOSAIC

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·March 12, 2019

    MONITOR, 100CC BURETTE W/ACORN FILTER

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code FPA·July 20, 2006

    CORNERSTONE-SR CAGE SYSTEM

    FDA Adverse Event
    Death ·MSD DEGGENDORF MFG·Product code ODP·February 17, 2012

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·May 27, 2020

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·April 4, 2011

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·June 16, 2008

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021

    CG COMPOSITE RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020

    DURAN ANCORE RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 16, 2023

    CG COMPOSITE RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·February 8, 2023

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018