BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    ATTAIN 6215 VENOGRAM BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040005996·Sterilization Tubing Cont Clr

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890122250·Zirlux Titanium Abutment 4.5 mmH, Non-Engaging,...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780774·LEVAMED ACTIVE ANKLE SUP SLVR L V

    SUNTANNING DEVICE (SEPAR. FROM K812225)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112250·Tap, 7.50mm, Cannulated, Fixed Sleeve

    OR TABLE/MAGNETOM OPEN VIVA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DOSIMETRY CHECK

    FDA 510(k)
    FDA Class 2 ·Radiology

    INNOVAMATRIX AC WOUND DRESSING WITH ANIMAL-DERIVED MATERIAL(S)

    FDA Adverse Event
    Injury ·CONVATEC TRIAD LIFE SCIENCES, LLC·Product code KGN·April 23, 2026

    GORE DUALMESH PLUS BIOMATERIAL

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code FTL·July 17, 2019

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 16, 2007

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·February 2, 2011

    CP5 FLOW MODULE

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWA·July 18, 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 Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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