10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746049927·WIRE SS POSTED WITH BALL POST UNIV 016 X 025 34...
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)
FDA 510(k)
FDA Unclassified
·Unknown
SonoSite SII Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
3.5MM TI PRE-BENT ROD 240MM 110DEG
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KWP·December 6, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 2015
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012