BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16711409300·

    Ardis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024334656·

    Ardis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024333925·

    ZEUS-P

    FDA UDI
    SPINAL ELEMENTS·00840916153410·Zeus-P Trial, 14 x 9 x 30mm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694046374·PrimaLIF LLIF PEEK Implant, 9mm X 26mm X 30mm, ...

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1671001409300·

    PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZILVER BILIARY STENT SYSTEM USW

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

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 3, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·June 21, 2011

    EXCEL SE

    FDA Adverse Event
    Injury ·DATEX-OHMEDA·Product code BSZ·August 28, 2008

    PROGREAT CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code KRA·March 11, 2015

    TOTAL KNEE REPLACEMENT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016

    PATIENT SPECIFIC TOTAL FEMUR

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018

    LOGIC CR FEMORAL POR, RIGHT, SZ 3

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 14, 2019

    GMK PRIMARY TIBIAL TRAY FIXED CEMENTED # 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·July 31, 2015

    PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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