30 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ClearPoint System and Accessories
FDA 510(k)
FDA Class 2
·Neurology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040187807·ZIRLUX ML DISC OM2 98x18
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112649·BARRON CORNEAL PUNCH 8.25MM
DEBAKEY NEEDLE PULLING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059542·DEBAKEY NEEDLE PULLING TISSUE FORCEPS TUNGSTEN ...
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
FDA 510(k)
FDA Class 1
·Ophthalmic
Clarius Ultrasound Scanner
FDA UDI
Clarius Mobile Health Corp·07540205001240·Portable Ultrasound Scanner
VITROS 250 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·October 15, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 10, 2011
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·July 1, 2013
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023
SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code LXH·September 24, 2018
ECCENTRICAL GLENOSPHERE DIA. 40 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code MBF·December 19, 2022
SUTURE ANCHOR, PEEK CORKSCREW FT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·September 24, 2018
SUTURE ANCHOR, PEEK CORKSCREW FT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·September 24, 2018