23 results
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42ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo.CT Lung CAD
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114247·VECTIS 2-HOLE 4MM 25GA (PK/10)
Edwards eSheath Introducer Set
FDA 510(k)
FDA Class 2
·Cardiovascular
MS-ONE, MODEL MS-1
FDA 510(k)
FDA Class 2
·Neurology
EDWARDS ESHEATH+ INTRODUCER SET
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYB·April 28, 2022
UNKNOWN EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·March 12, 2026
TF SHEATH UNKNOWN
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYB·July 18, 2023
UNKNOWN EDWARDS LIFESCIENCES SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·May 12, 2025
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES LLC·Product code NPT·December 5, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
STERRAD 100NX STERILIZER
FDA Adverse Event
Malfunction
·JABIL·Product code MLR·October 17, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 2, 2013
ESHEATH INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·December 17, 2021
UNKNOWN EDWARDS LIFESCIENCES SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·May 30, 2024
UNKNOWN EDWARDS INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2023
EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 20, 2022
UNKNOWN EDWARDS INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2023
EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 20, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021