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

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    NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056424·Zirlux Multi Anterior B1,98.5X14

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·10885862163622·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033380680·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011583·PedFuse Respond, CNL, 7.0mm x 45mm

    MIO ADVANCE

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·August 8, 2025

    MINIMED MIO ADVANCE

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·July 3, 2025

    CM DRIVE IMPLANT 4.3X11.5

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 13, 2018

    KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGI-VISION URETHRAL COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·March 20, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 9, 2011

    PLUM A+3 PUMP MEDNET WIRELESS

    FDA Adverse Event
    Injury ·HOSPIRA, INC.·Product code FRN·February 12, 2008

    BAIR HUGGER / 3M

    FDA Adverse Event
    Injury ·3M·Product code DWJ·November 23, 2016

    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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