13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SHOULDER FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70602901·Mini-Mono-Brackets Ricketts 'S' .018" 400 Brack...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306813450·Russian Tissue Forceps, 15cm
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0602000·Tray base, 2"
LAZERSMILE, LAZERWHITE
FDA 510(k)
FDA Class 1
·Dental
DASH 3000/4000 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
12 CM (5") PUR SMALLBORE TRIFUSE EXT SET, 3 CHECK VALVES, 3 CLAMPS, ROTATING LUE
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·November 25, 2019
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 11, 2013
CAPSURE EPI
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·April 15, 2011
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·June 10, 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