7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
HANSON SCAR ADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENVOY GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 24, 2015
EZ-28 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·December 17, 2010
1142 INTERMED TUBESET S/CHKVLVE PK/24-SH
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·July 17, 2014
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