35 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
FDA 510(k)
FDA Class 2
·Cardiovascular
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025
ELMED
FDA UDI
ELMED INCORPORATED·00842180160965·PRISM CERVICAL CURETTE 10" ANGLED 90° 5, BLACK
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522312070·
Module
FDA UDI
Biomet Orthopedics, LLC·00887868025860·
F³ FRAGMENT PLATING SYSTEMFRAGMENT PLATE HOLDER
FDA UDI
Biomet Orthopedics, LLC·00887868025952·
F³® FRAGMENT PLATING SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868448584·
F³® FRAGMENT PLATING SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868448607·
F3 FRAGMENT PLATING SYSTEMFRAGMENT PLATE BENDER - END
FDA UDI
Biomet Orthopedics, LLC·00887868025853·
F3® Fragment Plating System
FDA UDI
Biomet Orthopedics, LLC·00887868025969·
F³® FRAGMENT PLATING SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868448591·
F3® Fragment Plating System
FDA UDI
Biomet Orthopedics, LLC·00887868025945·
F3 FRAGMENT PLATING SYSTEMFRAGMENT PLATE BENDER
FDA UDI
Biomet Orthopedics, LLC·00887868025846·
SAFETY RELEASE ARCH BAR KIT
FDA 510(k)
FDA Class 2
·Dental
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
FDA 510(k)
FDA Class 2
·Ophthalmic
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026