68 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WAVE Clinical Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
NEUTROPHASE WOUND CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
VARIAX ELBOW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIZACT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·June 18, 2019
CUSTOM PROXIMAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
CUSTOMER PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 11, 2022
THREADED GLENOID BASEPLATE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 5, 2025
CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code JWH·January 8, 2015
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 14, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 14, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 1, 2011
CUSTOM DISTAL FEMORAL IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
UNK- NON- STANMORE HIP REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code KRO·June 25, 2015
CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
PROXIMAL FEMUR
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 19, 2014
CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·July 1, 2015
CUSTOM MID-SHAFT FEMUR
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 23, 2014
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Enforcement
Class II
·Completed·Hologic, Inc·December 18, 2024
DISTAL FEMUR JTS IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 19, 2014