24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER ARTHROSCOPE
FDA 510(k)
FDA Class 2
·Orthopedic
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·May 6, 2013
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code IKX·September 16, 2014
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·April 20, 2011
UNKNOWN EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·March 12, 2026
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
FDA Enforcement
Class I
·Terminated·Stryker Spine·August 28, 2013
ESHEATH INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·December 17, 2021
UNKNOWN EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 18, 2020
UNKNOWN EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 21, 2020
EDWARDS TRANSCATHETER TF SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 20, 2018
UNKNOWN EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 25, 2020
UNKNOWN EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 21, 2020
UNKNOWN EDWARDS LIFESCIENCES SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·May 30, 2024
EDWARDS TRANSCATHETER ESHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPU·November 20, 2018
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES LLC·Product code NPT·December 5, 2024
UNKNOWN EDWARDS SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 15, 2019
UNKNOWN EDWARDS SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 21, 2019
UNKNOWN EDWARDS SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 15, 2019