10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
AbClose - Port Site Closure Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
FDA 510(k)
FDA Class 2
·Cardiovascular
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANTA 2 BED
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FNL·June 20, 2013
PENTA 60-CM LENGTH PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 1, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
LASSOSTARNAV,10P,15MM DIA LOOP
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023
LASSOSTAR CATHETER
FDA Adverse Event
Death
·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020
LASSOSTAR NAV CIRCULAR MAPPING CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026