7 results
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35ms
·
Sources: EU EUDAMED, US FDA
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA
FDA 510(k)
FDA Class 1
·Ophthalmic
PACESAVER & SCOUT
FDA 510(k)
FDA Class 2
·Physical Medicine
CORRECT FLO INTRAVASCULAR ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 6, 2014
PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·November 29, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 30, 2010
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