249 results
·
22ms
·
Sources: EU EUDAMED, US FDA
AmpliVue Bordetella Assay
FDA 510(k)
FDA Class 2
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550216·GENUMEDI PT KNEE SUP SILVER R EW VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814299·GENUMEDI PT SILVER R VI
RAUMEDIC- ICP-MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
FDA 510(k)
FDA Class 2
·Orthopedic
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·May 28, 2013
*
FDA Adverse Event
Malfunction
·AESCULAP INC.·Product code MDM·September 26, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 28, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 12, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·January 27, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·April 26, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·October 22, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·November 22, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·November 23, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·February 29, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·January 13, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·April 6, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·December 22, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·December 30, 2011
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 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