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

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    MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040132890·Zirlux TR OM2 98x14mm

    Graftmaster

    FDA UDI
    ABBOTT VASCULAR INC.·08717648176524·GRAFTMASTER Coronary Stent Graft System 4.80 mm...

    Graftmaster

    FDA UDI
    ABBOTT VASCULAR INC.·08717648176517·GRAFTMASTER Coronary Stent Graft System 4.80 mm...

    Graftmaster

    FDA UDI
    ABBOTT VASCULAR INC.·08717648176500·GRAFTMASTER Coronary Stent Graft System 4.80 mm...

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427699·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427675·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427682·

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 8, 2019

    SET, EXTENSION, 60", M/M, 1.7 ML, ASV 50/BX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·December 16, 2024

    MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF

    FDA 510(k)
    FDA Class 2 ·Neurology

    ECAT ACCEL PET SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025

    FEMOSTOP

    FDA Adverse Event
    Malfunction ·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 21, 2003

    EXETER 2.5 I M PLUG 14MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·March 20, 2013

    ADAPTER SLEEVES 12/14 +2

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

    SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT

    FDA Adverse Event
    Injury ·OBTECH MEDICAL SARL·Product code LTI·March 12, 2008

    FEMOSTOP

    FDA Adverse Event
    Injury ·RADI MEDICAL SYSTEMS·Product code DXC·August 20, 2003

    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

    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