23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
BIS/EEG MODULE
FDA 510(k)
FDA Class 2
·Neurology
HI-TORQUE WINN
FDA UDI
ABBOTT VASCULAR INC.·08717648156816·HT WINN 40 Guide Wire .014" x 190 cm
CERASMART®
FDA UDI
Gc America Inc.·D0470124661·CERASMART 270 14 Unsvl B1 LT 5p
CERASMART™
FDA UDI
Gc America Inc.·14548161320498·CERASMART™ 270 14 Universal B1 LT 5p Block
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405178·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405673·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405659·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405703·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405697·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405680·
ACTICOAT COMPOSITE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
TETHER ACFS
FDA 510(k)
FDA Class 2
·Orthopedic
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code NQO·September 4, 2012
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code NQO·September 4, 2012
CRANIAL ACCESS KIT W/TWIST LOCK DRILL GUARD
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORP.·Product code HBF·January 20, 2005
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 15, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 9, 2011
SYNCHROMED
FDA Adverse Event
Malfunction
·NEUROLOGICAL DIVISION, MEDTRONIC, INC.·Product code LKK·March 12, 2008
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code NQO·September 4, 2012
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 2016