21 results
·
31ms
·
Sources: EU EUDAMED, US FDA
OMNI-JUG
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041089·ExtremiFuse Dual Cannulated Driver Handle
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192169·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111024·INSTRUMENT CADDY MEDIUM
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·September 2, 2011
SurgTech Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
TEM 3000 HEAD COIL
FDA 510(k)
FDA Class 2
·Radiology
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC VASCULAR IRELAND·Product code MIH·September 2, 2011
ANEURX STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·November 3, 2011
ANEURX STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·November 3, 2011
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 2, 2011
ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 2, 2011
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·September 2, 2011
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·May 13, 2014
CARELINK PROGRAMMER 2090X
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code NVZ·February 9, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 4, 2011
RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017