32 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALPHALOK Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120663·Guidewire 2.0x230mm Sgl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120656·Guidewire 2.0x230mm Drill Tip
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114162·ROBINS-KRATZ POLISHING CAN, 22GA PK/10
Stat Profile Prime Plus Analyzer System
FDA 510(k)
FDA Class 2
·Hematology
Capsule Vitals Plus Patient Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 3, 2023
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·January 15, 2024
UNSPECIFIED BD¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 7, 2023
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code PFO·January 15, 2024
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·September 1, 2011
GATEWAY PTA DILATION CATHETER
FDA Adverse Event
Malfunction
·NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP·Product code GBA·July 30, 2008
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 16, 2013
BD® BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·September 15, 2023
BD® BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 11, 2023
HERMETIC LUMBAR CATHETER, CLOSED TIP
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·August 19, 2019
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023