10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
FDA 510(k)
FDA Class 2
·Radiology
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
APPLIED GAUZE SPONGE 4X4X8
FDA 510(k)
FDA Unclassified
·Unknown
ELLIPSE DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 19, 2014
HI-TORQUE PROGRESS GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·October 25, 2010
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 24, 2012
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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