BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR

    FDA 510(k)
    FDA Class 2 ·Dental

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017736·K-Wire, Double Ended, Trocar Point, Diameter Si...

    ForPro

    FDA UDI
    Tng Worldwide, Inc.·00672047000161·Nitrile Vinyl Blend Exam Gloves Blue Size XL 100ct

    ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD·Product code MCM·April 9, 2019

    AMISTEM COLLARED STEM, HA COATED STEM SIZE 2 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 25, 2017

    2520274-2013-03033

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 31, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·October 3, 2014

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·May 31, 2011

    OPTIFLOW JUNIOR ADAPTOR KIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZA·April 29, 2016

    UNID ROD

    FDA Adverse Event
    Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

    UNID ROD

    FDA Adverse Event
    Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·December 22, 2015

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014