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

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    ELLIPSE PRECICE TRAUMA NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    7450 RV2 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136021591·7450 V2 SMALL W/HG & 2700 NRBV

    MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10

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

    PREPEX SYSTEM

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

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTL·September 23, 2015

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·May 15, 2013

    PROMETRA PROGRAMMABLE PUMP

    FDA Adverse Event
    Malfunction ·FLOWONIX MEDICAL INC.·Product code LKK·September 17, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 3, 2011

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·August 17, 2023

    ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code FTL·August 8, 2014

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·April 8, 2025

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTL·November 30, 2015

    TI-SU03 GC

    FDA Adverse Event
    Injury ·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015

    MUST MINI POLYAXIAL SCREW 3.5 X 20 FULL THREAD + NUT

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWP·February 2, 2018

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023