BEUDAMED
    64 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GXD·October 11, 2016

    Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

    FDA Recall
    Terminated ·Neurotherm, Inc.·Product code GXD·October 9, 2013

    Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210. The product is intended for coagulation of soft tissues in orthopedic, spinal and neuorsurgical applications.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GXD·April 13, 2010

    Radiofrequency Grounding Pad, REF RF-DGP-L

    FDA Recall
    Terminated ·Abbott Medical·Product code GXD·October 14, 2019

    NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000

    FDA Recall
    Terminated ·Abbott Laboratories Inc. (St Jude Medical)·Product code GXD·April 22, 2021

    Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·January 16, 2012

    AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code IZL·June 6, 2014

    AGFA DX-D 100 is a mobile digital radiography x-ray system

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IZL·May 29, 2015

    AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·July 30, 2014

    AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·June 12, 2013

    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

    FDA Enforcement
    Class II ·Terminated·Agfa-Gevaert, N.V.·January 16, 2019

    DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

    FDA Recall
    Terminated ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code KPR·August 15, 2018

    AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.

    FDA Recall
    Terminated ·AGFA Corp.·Product code IZL·May 15, 2013

    DX-D600 - DXD Imaging Package

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code KPR·May 2, 2016

    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code KPR·July 2, 2014

    DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

    FDA Recall
    Terminated ·Agfa-Gevaert, N.V. Prins Boudewijnlaan Kontich Belgium·Product code KPR·December 4, 2018

    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JWH·July 1, 2021

    DX-D600 - DXD Imaging Package

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·April 12, 2017

    DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

    FDA Enforcement
    Class II ·Terminated·Agfa N.V.·October 3, 2018