34 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COPSIOS BONE VOID FILLER (BVF)
FDA 510(k)
FDA Class 2
·Orthopedic
GORE 3.0T TORSO ARRAY
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 16, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 16, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 16, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 22, 2024
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·March 25, 2015
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 6, 2013
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·3006356043 JOHNSON & JOHNSON MEDICAL·Product code NDJ·September 16, 2014
ARTICUL/EZE BALL 28 +1.5 GR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 12, 2011
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
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·November 30, 2021
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·January 17, 2023
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 16, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 18, 2019
ESW PROSTHESIS, ESOPHAGEAL
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 5, 2019
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·December 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·December 5, 2019