9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DICOM THEATER
FDA 510(k)
FDA Class 2
·Radiology
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 17, 2014
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 15, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 9, 2010
Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code IYE·April 19, 2010
Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA The product is a radiation treatment planning system.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code IYE·May 29, 2008
Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extra cranial and consist of single-session or fractionated delivery.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code GKZ·June 10, 2010