BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Safco Gates Glidden Drills

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310222033·Safco Gates Glidden drills, #01, 28mm, 6/box

    Cook

    FDA UDI
    COOK INCORPORATED·00827002140363·Whistle Tip Ureteral Catheter (Left)

    Cardiovascular Procedure Kit

    FDA UDI
    Terumo Cardiovascular Systems Corporation·00699753461321·

    PADPRO MODEL #2516

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CLAY-PARK LABS, INC. - LUBRICATING JELLY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ZPower Rechargeable System for Hearing Aids

    FDA UDI
    ZPOWER, LLC·00811204030225·Battery Door Module for ZPower Rechargeable Sys...

    IMMULITE 2000

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012

    IMMULITE 2000

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012

    PS TIBIAL INSERTS SZ 4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 17, 2024

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·March 26, 2013

    COBAS 6000 CORE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code KTO·March 17, 2011

    CONCERTO

    FDA Adverse Event
    Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code FPO·March 26, 2008

    IMMULITE 2000 INSULIN

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012

    IMMULITE 2000 INSULIN

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012

    BD ALARIS¿ SMARTSITE¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 23, 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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014