BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126601·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450293409·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033442494·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033442517·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033442500·

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015

    WECK CARDIAC PACING WIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARDYDISK LOMEFLOXACIN, 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015

    CRANIAL ACCESS KIT W/TWIST LOCK DRILL GUARD

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORP.·Product code HBF·January 20, 2005

    M2A MAGNUM MODULAR HEAD 48MM HEAD DIAMETER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·September 2, 2016

    ALTRX +4 NEUT 36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·March 20, 2013

    ASR UNI FEMORAL IMPL SIZE 47

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

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·March 11, 2008

    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