26 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496072706·STRIPE GAME CALIPSO, SIZE S, NERO, GRADUATED CO...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180503003·Distractor Tip, Lamina, Short, No Offset, Right
Phonak
FDA UDI
Phonak AG·07612847978331·Naída S CRT IX (black)
IM2001 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
FDA 510(k)
FDA Class 2
·Hematology
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 31, 2010
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code LXH·April 23, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 31, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024
BD SOLOMED¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·April 17, 2018