8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
IMPACT MODELS 701, 702 AND 703
FDA 510(k)
FDA Class 2
·Anesthesiology
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074229232·PLATE 6861272 72.5MM FSP ANTERIOR CRV
Supreme and Response Electrophysiology Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
CENTRIA T4 RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·October 1, 2010
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·November 2, 2012
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