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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    DUAL LUMEN MIDLINE CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890103490·Zirlux 30 Degree Multi-Unit Abutment 4.5 mmH co...

    VOMED VOLZER MEDIZINTECHNIK GMBH & CO.KG

    FDA registration
    VOMED VOLZER MEDIZINTECHNIK GMBH & CO.KG·8 products·🇩🇪 Germany

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033151129·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033151136·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024045·Paddle Shaver, 9mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103090·Shaver, Closed, 9mm

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·May 22, 2015

    MOTORIZED MICRO MULTILEAF COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARDIOVISE ECG INTERPRETATIVE SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 8, 2024

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD·Product code JDI·March 19, 2013

    GLOVE INSTAGARD PF SYN EXAM (VINYL) SZ S

    FDA Adverse Event
    Product code LYZ·March 8, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·H10·Product code KWP·April 4, 2013

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024