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

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    HORIZONS ERCP CANNULA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Procure

    FDA UDI
    Twin Med, LLC·10840330700051·Comfort Soft Plus Adult Nasal Cannula Soft Tubi...

    Comfort Soft Plus

    FDA UDI
    WESTMED, INC.·00709078014161·Comfort Soft Plus Adult Nasal Cannula Soft Tubi...

    Astra

    FDA UDI
    Preat Corporation·00842092102633·Astra®-compatible Lilac 4.5/5.0mm Non-Engaging ...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776088576·Cooley Pedeatric Clamp

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159007947·Baby VascularClamp With Angled Atraumatic Jaw

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·10885862161536·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361008927·PedFuse Reset, CNL, 7.0mm x 35mm

    OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INSYTE CATHETER, INSYTE AUTOGUARD CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·May 5, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·March 13, 2013

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 20, 2008

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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