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

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    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106160·Trial, 26 x 16mm, 8 Degree, Tapered, Straight

    DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033184059·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033184011·

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100160·Compressor, Canoe

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033184042·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033183984·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033183960·

    INSET I

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 1, 2025

    MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 12, 2025

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·March 8, 2011

    ATLAS II + DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    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