9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
STERILE DISPOSABLE WET SKIN SCRUB TRAY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMC
FDA UDI
Advantage Medical Electronics, LLC·00849593021654·Philips BP Cable(HP-3 Monitor)
HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33
FDA 510(k)
FDA Class 2
·General Hospital
STARCAM 4000
FDA 510(k)
FDA Class 1
·Radiology
DEPUY - ULTAMET - METAL ON METAL INSERT
FDA Adverse Event
Injury
·Product code KWA·January 17, 2013
ACCESS 2I (LXI) IMMUNOASSAY SYSTEM
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·December 3, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·January 14, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code FPA·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