7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CRITICAL CARE HOSPITAL BED (ICU/CCU)
FDA 510(k)
FDA Class 2
·General Hospital
RIVER MEDICAL MICRODRILL SYSTEM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501
FDA 510(k)
FDA Class 2
·Radiology
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·June 5, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·January 9, 2013
NVPRM PB CLV OL100IN
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·November 4, 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