36 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAYO SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896099586·MAYO SCISSORS CURVED BEVELED BLADES POWER CUT GOLD
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016971·MFx™ 2.0mm Rainbow Pilot Drill, Blunt Cannula, ...
TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060678·TISSUE FORCEPS MICROSCOPIC CURVED TUNGSTEN CARB...
UNICEM
FDA 510(k)
FDA Class 2
·Dental
CAP PORP, CAP TORP
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EDWARDS ESHEATH+ INTRODUCER SET
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYB·April 28, 2022
UNKNOWN EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·March 12, 2026
TF SHEATH UNKNOWN
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYB·July 18, 2023
UNKNOWN EDWARDS LIFESCIENCES SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·May 12, 2025
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES LLC·Product code NPT·December 5, 2024
OPHTHALMIC FEMTOSECOND LASER
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021
TANDEM T:SLIM DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021