8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TURBOX FIBRINOGEN
FDA 510(k)
FDA Class 2
·Hematology
LP-5
FDA 510(k)
FDA Class 2
·Anesthesiology
H.R. JAKOBI SURG. INSTRUMENTS #9 48
FDA 510(k)
FDA Class 2
·Anesthesiology
UNIVERSAL OSCILLATING SAW ATTACHMENT
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.·Product code GFA·May 20, 2014
WAVESCAN WAVEFRONT SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code HKO·October 7, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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