9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAICHEM(TM) AMMONIA REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Legacy™3 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307102557·4.7mmD x 6mmL, 4.5mmD Platform
TRICON REVISION TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIGITAL FASHION THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 10, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 12, 2010
KAPPA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DXY·December 10, 2012
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