49 results
·
23ms
·
Sources: EU EUDAMED, US FDA
COMPLETE BRAND MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134090·Trial, TLIF, 27L OB STR 7Deg, 9mm
SONOMA
FDA UDI
FGX INTERNATIONAL INC.·00193033496367·
U-SYSTEMS ULTRASOUND SYSTEM USI-2000
FDA 510(k)
FDA Class 2
·Radiology
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
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
PROXIMATE PPH PROCEDURE SET
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 20, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 3, 2011
DA+ C SERIES SR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DXY·March 10, 2008
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