35 results · 39ms · Sources: EU EUDAMED, 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