48 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ICSI CUMULASE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INTERMED ZOOM COLPOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code GWF·February 20, 2018
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·December 2, 2013
NIM-ECLIPSE® PATIENT MODULE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·December 6, 2017
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 6, 2011
PROBE SPK1004 SURGEON CONTROLLED
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·May 17, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 28, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 29, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 3, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code OYC·December 15, 2016
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 29, 2013
ONE TOUCH ULTRASMART METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 22, 2008
PORT-A-CATH
FDA Adverse Event
Injury
·BARD ACCESS SYSTEM·Product code LJT·April 26, 2011
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 27, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·December 24, 2017
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 1, 2017