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

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    Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HEALIX AWL/TAP

    FDA UDI
    DEPUY MITEK, LLC·10886705007721·HEALIX Awl/Tap 6.5mm

    LCP

    FDA UDI
    Synthes GmbH·10886982156617·LCP PROXIMAL LATERAL TIBIA PLATE 9 HOLES/220MM-...

    TAPERLOC COMPLETE

    FDA UDI
    Biomet Orthopedics, LLC·00880304532120·

    Taperloc® Complete Instrument

    FDA UDI
    Biomet Orthopedics, LLC·00887868508868·

    VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERILE RADIOLUCENT SKULL PINS

    FDA 510(k)
    FDA Class 2 ·Neurology

    ECLIPSE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·October 31, 2008

    NX3 DUAL CURE CLEAR

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·August 24, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 11, 2021

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·May 15, 2014

    GORE® VIABIL® BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code FGE·September 1, 2023

    ETHIBOND WHT 5-0 45CM S14 (2)

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·January 10, 2023

    IFUSE IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·SI-BONE, INC.·Product code OUR·July 3, 2018

    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·September 26, 2012

    SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·February 25, 2026