32 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Smart SPACE Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112861·CORNEAL TREPHINE BLADE6.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112809·BARRON VACUUM PUNCH 8.75MM
POWDERED VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill
FDA 510(k)
FDA Class 2
·Orthopedic
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 26, 2021
ENDO GIA
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·December 27, 2021
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·May 18, 2021
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Death
·COVIDIEN MFG DC BOULDER·Product code GEI·May 20, 2021
UNKNOWN EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·June 1, 2021
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·May 7, 2022
GE OEC 7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 16, 2008
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 5, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
CELLEBRITY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code BTG·February 24, 2025
ENDO GIA
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·May 10, 2021
MAGNETOM Vida Fit. Model Number: 11410481.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·April 4, 2022
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 17, 2021