BEUDAMED
    107 results · 15ms · 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 ×

    RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

    FDA Recall
    Terminated ·Virtual Imaging, Inc.·Product code MQB·November 2, 2018

    Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.

    FDA Recall
    Terminated ·Virtual Imaging, Inc.·Product code IZL·September 22, 2014

    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Enforcement
    Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·August 20, 2014

    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Enforcement
    Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·August 20, 2014

    RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

    FDA Enforcement
    Class II ·Terminated·Virtual Imaging, Inc.·November 21, 2018

    Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.

    FDA Enforcement
    Class II ·Terminated·Virtual Imaging, Inc.·February 18, 2015

    The ZYTO Tower is the input device to program the software with various virtual items.

    FDA Recall
    Terminated ·ZYTO Technologies, Inc.·Product code GZO·November 23, 2015

    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code MWI·July 17, 2014

    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code MWI·July 17, 2014

    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·January 18, 2017

    The ZYTO Tower is the input device to program the software with various virtual items.

    FDA Enforcement
    Class II ·Terminated·ZYTO Technologies, Inc.·July 13, 2016

    Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code ELW·November 9, 2016

    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code ELW·November 9, 2016

    Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code ELW·November 9, 2016

    Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent, Inc.·December 14, 2016

    Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent, Inc.·December 14, 2016

    RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.

    FDA Recall
    Terminated ·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·July 13, 2015

    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent, Inc.·December 14, 2016

    Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code JXG·July 3, 2014

    Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code JXG·July 3, 2014