51 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANSPACH DISSECTION TOOLS
FDA 510(k)
FDA Class 2
·Neurology
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
7400 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136021195·7400M 2730 LG 2W NRBV 220D EXH
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
FDA 510(k)
FDA Class 2
·Radiology
AXSOS (TM) LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 15, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
EYE STRETCHER CHAIR
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 25, 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