67 results
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23ms
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Sources: EU EUDAMED, US FDA
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
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
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
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
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
Codman Certas - In Line Valve Only; Product Code: 82-8800 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 Catheter and Accessories; Product Code: 82-8802 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
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·June 25, 2015
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 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 SIPHONGUARD Device, Catheter and Accessories; Product Code: 82-8805 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 only with SIPHONGUARD Device; Product Code: 82-8804 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 SIPHONGUARD, Unitized Catheter and Accessories; Product Code: 82-8806 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
Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; Reference/FSCA Identifier: CP-07007, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·December 12, 2011
Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.
FDA Recall
Terminated
·Volcano Corporation·Product code IYO·June 29, 2010