38 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
i-STAT Hematocrit test with i-STAT Alinity System
FDA 510(k)
FDA Class 2
·Hematology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638588·CoRoent Ant TLIF PEEK, 16x13x34mm 12°
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
FDA 510(k)
FDA Class 2
·Radiology
3.0T METAFLEXCOIL
FDA 510(k)
FDA Class 2
·Radiology
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·March 17, 2020
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 11, 2013
PINNACLE MTL INS NEUT36IDX60OD
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWA·July 8, 2011
HS HAND CONTROLLED CURVED SHEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·September 10, 2008
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 13, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 19, 2019
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 20, 2019
KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 21, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·April 14, 2022
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
KANEKA PTCA CATHETER CO-R8 (TASUKI)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·December 13, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·December 21, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·April 13, 2022
KANEKA PTCA CATHETER CO-R6 (RAIDEN3)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 6, 2025
KANEKA PTCA CATHETER ZINRAI
FDA Adverse Event
Death
·KANEKA CORPORATION·Product code LOX·February 3, 2025