23 results
·
31ms
·
Sources: EU EUDAMED, US FDA
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
CERASMART™
FDA UDI
Gc America Inc.·14548161320429·CERASMART™ 270 14 Universal A3 HT 5p Block
CERASMART®
FDA UDI
Gc America Inc.·D0470124581·CERASMART 270 14 Unsvl A3 HT 5p
MICRO VISION OPTICAL
FDA UDI
FGX INTERNATIONAL INC.·00193033402788·
MICRO VISION OPTICAL
FDA UDI
FGX INTERNATIONAL INC.·00193033402795·
MICRO VISION OPTICAL
FDA UDI
FGX INTERNATIONAL INC.·00193033402757·
MICRO VISION OPTICAL
FDA UDI
FGX INTERNATIONAL INC.·00193033402801·
MICRO VISION OPTICAL
FDA UDI
FGX INTERNATIONAL INC.·00193033402764·
MICRO VISION OPTICAL
FDA UDI
FGX INTERNATIONAL INC.·00193033402771·
MICRO VISION OPTICAL
FDA UDI
FGX INTERNATIONAL INC.·00193033402818·
THE MAESTRO SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
FDA 510(k)
FDA Class 2
·Orthopedic
XPS® BUR - STYLUS TRANSNASAL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·March 16, 2017
IPC® STYLUS TRANSNASAL BUR
FDA Adverse Event
Death
·MEDTRONIC XOMED INC.·Product code ERL·February 4, 2015
AESTIVA 7900
FDA Adverse Event
Injury
·DATEX-OHMEDA·Product code BSZ·March 15, 2013
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 9, 2011
PRECISION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 12, 2008
UNKNOWN MONO/POLYAXIAL SCREWS
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·March 11, 2020
UNKNOWN MONO/POLYAXIAL SCREWS
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·March 11, 2020
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016