8 results
·
31ms
·
Sources: EU EUDAMED, US FDA
FRAME
FDA 510(k)
FDA Class 1
·Ophthalmic
3M™ ESPE™
FDA UDI
3M COMPANY·30605861030497·3M™ ESPE™ Gold Anodized Crown Refills, First Mo...
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FRESENIUS 2008K
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 19, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·February 2, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·December 29, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020