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

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    ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DAISY FUENTES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033150962·

    DAISY FUENTES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033150986·

    DAISY FUENTES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033150993·

    VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MODIFICATION TO ARTOSCAN M

    FDA 510(k)
    FDA Class 2 ·Radiology

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025

    XPS® BUR - STYLUS TRANSNASAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·March 16, 2017

    INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 13, 2025

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

    LCS COMP RP INSERT STD+ 20MM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code NJL·March 19, 2013

    SOFTCLIX® PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 8, 2011

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

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 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

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018