53 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
Pilot Spinal System
FDA UDI
Life Spine, Inc.·00190837051525·Pilot Torque Limiting 1/4in T-Handle 100lbs Black
VASCUTRAK PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION OF NC-STAT
FDA 510(k)
FDA Class 2
·Neurology
CATALYS LASER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 24, 2024
CATALYS LASER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 15, 2013
VERSYS HIP SYSTEM FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·May 31, 2011
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·April 24, 2026
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·October 30, 2023
CATALYS SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code OOE·November 1, 2022
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 26, 2026
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·Product code OOE·October 12, 2021
CATALYS SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code OOE·November 1, 2022
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·May 21, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·May 21, 2021
OPHTHALMIC FEMTOSECOND LASER
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·August 12, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·August 13, 2021