35 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KEELER KAPTURE SOFTWARE
FDA 510(k)
FDA Class 2
·Ophthalmic
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015374407·STANDARD LOCKING SCREW L45.0MM D4.0MM
Cancellous Screw, Cannulated
FDA UDI
I.T.S. GmbH·09120034306075·Cancellous Screw, Cannulated, D=4.0mm, L=50mm
Thermoflect
FDA UDI
Encompass Group, L.L.C.·30612899514455·THERMOFLECT JACKET, L, 25EA ...
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015373905·STANDARD LOCKING SCREW L45.0MM D4.0MM STERILE
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981161576·Z-Rod, Dia. 6.0mm, Co-Cr, 450mm
VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
FDA 510(k)
FDA Class 2
·Immunology
I-ROOT
FDA 510(k)
FDA Unclassified
·Unknown
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·March 19, 2019
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC, CRMD·Product code MXC·January 13, 2014
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·May 31, 2013
CORE MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 17, 2011
UNKNOWN SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 16, 2023
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·July 25, 2025
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·January 20, 2026
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·HEARTWARE, INC·Product code DSQ·March 28, 2016
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·March 18, 2016
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·October 15, 2025