8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
FDA 510(k)
FDA Class 1
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707085133·WEB I MOL BANDS G8424-17+G2820-00 LL1
FEMORAL ANGIOGRAPHY DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LIGAMAX 5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 26, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 11, 2010
DIGITAL RADIOGRAPHY CXDI-50G
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·December 31, 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