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

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    Avicenna Roboflex

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

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101179·GILL CORNEAL KNIFE STRAIGHT

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376364742·IdentiTi ALIF SA, T25 Driver, Straight

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702778670·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...

    MAMMOTOME EX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 7, 2006

    MAMMOTOME EX HAND HELD SYSTEM

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

    ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS

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

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 31, 2022

    INCA 9F COMPLETE SET,EO

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code BZD·August 30, 2019

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 2, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 1, 2015

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019