49 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUCEA LED SURGICAL LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
5570 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021577·5570 3L SYR PER SIBEL MED
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045791·Paddle Shaver, 7mm
AXIS PACS, HMS PACS
FDA 510(k)
FDA Class 2
·Radiology
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 9, 2025
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
ATLANTIS? SR PRO²
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·May 15, 2013
ARDIS INSERTER - 9MM
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code MAX·September 17, 2014
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·June 1, 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