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

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    SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)

    FDA 510(k)
    FDA Class 2 ·Neurology

    XPS® BUR - STYLUS TRANSNASAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·March 16, 2017

    CERASMART™

    FDA UDI
    Gc America Inc.·14548161320405·CERASMART™ 270 14 Universal A2 HT 5p Block

    CERASMART®

    FDA UDI
    Gc America Inc.·D0470124571·CERASMART 270 14 Unsvl A2 HT 5p

    MICRO VISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033402733·

    MICRO VISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033402702·

    MICRO VISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033402726·

    MICRO VISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033402719·

    MICRO VISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033402689·

    MICRO VISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033402740·

    MICRO VISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033402696·

    !NSURE FECAL OCCULT BLOOD TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 16, 2017

    IPC® STYLUS TRANSNASAL BUR

    FDA Adverse Event
    Death ·MEDTRONIC XOMED INC.·Product code ERL·February 4, 2015

    SCOTCHBOND ETCHANT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·3M ESPE DENTAL PRODUCTS·Product code KLE·March 15, 2013

    CONSULTA CRT-D

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·March 9, 2011

    ACTIVELIFE 1PC - 1 PC DRAINABLE POUCH W/ STOMAHESIVE(SH)

    FDA Adverse Event
    Injury ·CONVATEC DOM. REPUBLIC INC·Product code EZQ·July 31, 2014

    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