9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
GLUCOSE HK-60 ASSAY KIT CAT. #201-39
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Endodontic Hand Instruments
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668606251·Senseus Flexofile Size 006 25mm
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
FDA 510(k)
FDA Class 2
·Neurology
Disposable Hot Biopsy Forceps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·October 7, 2010
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MQUET CARDIOVASCULAR LLC·Product code GEI·December 5, 2012
11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·July 20, 2018
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