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

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    GUIDING CATHETERS 9F JL4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556706067·GC Initial™ LF Powder Opaq. Mod. OM-5, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710211·GC Initial™ LF Powder Opaq. Mod. OM-5, 20g

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292367·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704912251·

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771048739·K-Wires, Double trocar, .028-inch (0.7mm) diame...

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659483910·K-Wire w. double end trocarpoint _x000D_...

    K-Wire w. double end trocarpoint 0.70mm/152mm, 6 pcs./unit

    FDA UDI
    mahe medical gmbh·EMAHKM710210·K-Wire w. double end trocarpoint 0.70mm...

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011871021000·Standard Band, Tooth 47-46/36-37, Size 21

    AUTO-CLIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JO Agapé Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EVOLUTION ESOPHAGEAL STENT SYSTEM

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code ESW·October 8, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 12, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015