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

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    OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARTO XP SYSTEM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, LTD·Product code DQK·November 30, 2007

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·August 14, 2008

    TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    GRAMS POLYPROPYLENE NONABSORBABLE SUTURE

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

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER LTD. (HAIFA, ISREAL)·Product code DQK·April 17, 2008

    ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 17, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE AND CO. KG·Product code NVZ·April 11, 2011

    MARATHON MICRO CATHETER

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code KRA·June 18, 2008

    INFUSOMAT SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·September 25, 2017

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·August 3, 2022

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·February 16, 2023

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 25, 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