13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609811·BioQuick-Brackets Roth .018" 20 Brackets 3-5 w....
GSA GENITO SENSORY ANALYZER
FDA 510(k)
FDA Class 1
·Neurology
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX
FDA 510(k)
FDA Class 2
·Dental
BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·December 28, 2018
1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR
FDA Adverse Event
Injury
·SYNTHES USA·Product code MQN·April 16, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·March 14, 2011
HYDROCOIL 14-SYSTEM COIL (HES)
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code HCG·June 12, 2008
HUIBREGTSE NEEDLE KNIFE PAPILLOTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·July 19, 2022
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·March 21, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022