10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ELECTROSURGICAL LOOP ELECTRODE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BICONTACT HIP STEM AND FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
ELISIO-H HEMODIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ISODUR PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015
SALTO TALARIS TOTAL ANKLE PROSTHESIS
FDA Adverse Event
Injury
·TORNIER SAS·Product code HSN·June 18, 2014
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·December 23, 2010
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
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