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

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    VBR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890122540·Zirlux Titanium Abutment 6 mmH compatible with:...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040040324·Disposable Face Shield

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033379417·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033379431·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033379424·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033379400·

    COOK PRESSURE MONITORING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EAR THERMOMETER, MODELS ST613C AND ST613F

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COMFORT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.A DE C.V·Product code FPA·October 22, 2025

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 12, 2013

    54 CM BIPOLAR LEAD

    FDA Adverse Event
    Malfunction ·GREATBATCH MEDICAL·Product code DTB·February 2, 2011

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·July 30, 2014

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 30, 2025

    Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 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