BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    REPROCESSED HARMONIC

    FDA 510(k)
    FDA Unclassified ·Unknown

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427286·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427293·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427309·

    MULITPLE MALE LATX CONDOM

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

    ADC QS/IPD WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECAREMANAGER V3.6

    FDA Adverse Event
    Malfunction ·VISICU·Product code MSX·September 21, 2009

    ECAREMANAGER V3.6

    FDA Adverse Event
    Malfunction ·VISICU·Product code MSX·December 14, 2009

    FEMOSTOP

    FDA Adverse Event
    Malfunction ·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 21, 2003

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·March 20, 2013

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    THERMACHOICE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code MKN·March 12, 2008

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·June 27, 2012

    FEMOSTOP

    FDA Adverse Event
    Injury ·RADI MEDICAL SYSTEMS·Product code DXC·August 20, 2003

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·June 27, 2012

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020