11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner
FDA 510(k)
FDA Class 2
·Orthopedic
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169599468·TRIAL 2193560 O25 IB 27MM 18 DEG 16X60
SHASER IPL HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UPCERA ZIRCONIA BLANKS
FDA 510(k)
FDA Class 2
·Dental
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·December 14, 2023
Junction Box - 1104343 and 1193560
FDA Recall
Terminated
·Invacare Corporation·Product code LLI·December 2, 2016
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017
PLUM XLM W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 14, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 25, 2013
STRATOS
FDA Adverse Event
Injury
·MEDXPERT GMBH·Product code HRS·September 11, 2014
Junction Box - 1104343 and 1193560
FDA Enforcement
Class II
·Terminated·Invacare Corporation·February 15, 2017