46 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Asthma Monitor AM3
FDA 510(k)
FDA Class 2
·Anesthesiology
NOVEL TAPERED HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOCRYL X
FDA 510(k)
FDA Class 2
·Dental
CATALYS LASER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 24, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
CATALYS LASER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 18, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
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