7 results
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34ms
·
Sources: EU EUDAMED, US FDA
SUCROSEP HUMAN PROLACTIN (HPR) IRMA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
da Vinci Xi Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ERCH ARCH BAR, MODEL 38-690-00
FDA 510(k)
FDA Class 2
·Dental
PDS II (POLYDIOXANONE) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code NEW·October 1, 2010
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·November 2, 2012
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
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