11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE
FDA 510(k)
FDA Class 2
·General Hospital
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306815034·Foerster Sponge Forceps, Straight, Serrated, 24cm
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Y-TZP POWDER AND PROCERA ALLZIRKON
FDA 510(k)
FDA Class 2
·Dental
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·January 26, 2012
9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDS·April 22, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·April 14, 2011
AUTOCLAVABLE HANDLES, OVERMOLDED
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code LDD·June 30, 2008
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