8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Bioseal Inc.
FDA UDI
BIOSEAL·00630094197340·Tubing Set 4 1/4" w/Connector
MODIFICATION TO AURORA MRI SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SRT-100+
FDA 510(k)
FDA Class 2
·Radiology
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 22, 2013
PRECISION XCEED PRO
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·January 30, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·August 1, 2014
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2015