9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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#920 DISPOSABLE TUR CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LARGE AO COUPLING ASNIS III HALL FITTING
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 25, 2012
FEMTEST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OP-CON SURGICAL INSTRUMENTS #4
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRIAGE BNP TEST FOR BECKMAN COULTER
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code NBC·May 19, 2014
PLASMABLADE TNA TISSUE DISSECTION DEVICE
FDA Adverse Event
Other
·PEAK SURGICAL, INC.·Product code GEI·October 14, 2010
MEDTRONIC ANEURX STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 21, 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 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