9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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N/A
FDA UDI
Key Scientific Products Incorporated·00850041798028·PEP REAGENT
N/A
FDA UDI
Key Scientific Products Incorporated·00850041798042·Pep ReagentT
STRYKER HIP ARTHOROSCOPY SET
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
FDA 510(k)
FDA Class 2
·Orthopedic
THERAKOS CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Injury
·THERAKOS·Product code LNR·February 25, 2013
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·January 14, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024