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

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    REDUCED SIZE ONCOLOGY SALVAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    ALLROUND 55 LF

    FDA 510(k)
    FDA Class 2 ·Dental

    WIENER LAB. UREA UV CINETICA AA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HYBRID GLENOID IMPACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HWA·September 10, 2019

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    COMPR RVS GLENO 2-PRNG INS/IMP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWS·September 10, 2019

    SIDEKICK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·March 21, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 16, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·March 28, 2008

    SPEEDSTITCH MAGNUMWIRE SUTURE CARTRIDGES

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GAT·March 21, 2012

    SPEEDSTITCH MAGNUMWIRE SUTURE CARTRIDGES

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GAT·March 21, 2012

    SPEEDSTITCH SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GAT·March 21, 2012

    SPEEDSTITCH MAGNUMWIRE SUTURE CARTRIDGES

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·March 21, 2012

    SPEEDSTITCH SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GAT·March 21, 2012

    CR TIBIAL INSERT SZ 4, 9MM, SLOPE +

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 15, 2023

    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·April 6, 2016

    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