7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
KULTSURE (CATALOGUE NO. M240)
FDA 510(k)
FDA Class 1
·Microbiology
BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JEY·December 6, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 2015
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