8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNERGY CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPEEDLINK TRANSVERSE CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
OPTIBOND SOLO PLUS ACTIVATOR
FDA 510(k)
FDA Class 2
·Dental
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 3, 2013
NEXGEN LPS-FLEX GSF FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·August 21, 2014
SURESTEPPRO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN·Product code CGA·May 13, 2011
CAP FOR INJECTOR MEMBRANE M50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·May 4, 2021
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022