10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION
FDA 510(k)
FDA Class 3
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613023867·Metzenbaum Scissors, Straight, Delicate/Slender...
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G5869132040·osteotome caps, gas or steam permeable, latex-f...
Cryocheck Chromogenic Factor VIII
FDA 510(k)
FDA Class 2
·Hematology
AQUIFY LENS COMFORT DROPS
FDA 510(k)
FDA Class 2
·Ophthalmic
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 14, 2013
NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE
FDA Adverse Event
BECKMAN COULTER INC.·Product code CJE·December 2, 2010
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 3, 2014
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023