8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFIED OLSEN 755/756 SWITCHPENS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OP-CON SURGICAL INSTRUMENTS #4
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NOVA MAX GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORPORATION·Product code NBW·October 15, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·December 21, 2012
TRIAGE CARDIAC PANEL 25 TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO INC·Product code MMI·May 19, 2014
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012