665 results
·
46ms
·
Sources: EU EUDAMED, US FDA
LYONS DISSECTING
FDA Adverse Event
Malfunction
·GYRUS MEDICAL, INC.·Product code GEI·June 5, 2007
The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray.
FDA Recall
Terminated
·Gyrus Acmi, Incorporated·Product code GCJ·August 3, 2010
OLYMPUS FLEXIBLE SURGICAL INSTRUMENTS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code KNW·March 15, 2011
VISUALASE
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code GEX·December 18, 2020
OLYMPUS RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·October 29, 2010
OLYMPUS RESECTION SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP·Product code FED·October 21, 2011
GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·May 7, 2024
GORE® TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DQY·May 9, 2024
OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE
FDA Adverse Event
Other
·OLYMPUS WINTER & IBE GMBH·Product code JOS·July 14, 2010
GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK
FDA Recall
Terminated
·Gyrus Acmi, Incorporated·Product code GEI·August 6, 2010
GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.
FDA Recall
Terminated
·Gyrus Medical, Inc.·Product code GEI·May 15, 2006
GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·May 9, 2024
OLYMPUS OES CYSTONEPHROFIBERSCOPE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAJ·August 26, 2010
Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.
FDA Recall
Terminated
·Gyrus ACMI Corporation·Product code GEI·August 18, 2009
Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.
FDA Recall
Terminated
·Gyrus ACMI Corporation·Product code GEI·August 18, 2009
Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.
FDA Recall
Terminated
·Gyrus ACMI Corporation·Product code GEI·August 18, 2009
PKS OMNI
FDA Adverse Event
Other
·GYRUS MEDICAL INC.·Product code GEI·March 6, 2012
OMNI PKS
FDA Adverse Event
Malfunction
·GYRUS MEDICAL, INC.·Product code GEI·February 20, 2012
BICOAG HEMOSTATIC PROBE
FDA Adverse Event
Other
·GYRUS MEDICAL, INC.·Product code KNS·March 14, 2012
LYONS PLASMAKINETIC DISSECTING FORCEPS
FDA Adverse Event
Other
·GYRUS MEDICAL INC.·Product code GEI·February 29, 2012