BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    Senhance Surgical Robotic System

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

    Neuro Cochlear Implant System

    FDA UDI
    NEURELEC·03663227002126·EAR PLUG, RETENTION KIT NEURO2

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292626·

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK111201·DD tempMED are pre-colored dental milling blank...

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704511048·

    Stainless Steel Femoral Nailing System

    FDA UDI
    ORTHOFIX SRL·18032568033717·FLEXIBLE REAMER D 12.0 MM

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383544016·Gutta Percha Points is used to root canal filin...

    VALLEYLAB

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·October 1, 2024

    CSM SUBMERGED-R IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999

    FDA 510(k)
    FDA Class 2 ·Neurology

    ISA CO2

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 11, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 14, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    FDA Adverse Event
    Injury ·BIOENTERICS CORP·Product code LTI·September 18, 2008

    PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·August 11, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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