10 results
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19ms
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Sources: EU EUDAMED, US FDA
IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609291·Mini Sprint-Brackets Roth .022" 400 Brackets
SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5
FDA 510(k)
FDA Class 2
·Radiology
PROLITE PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
12/14 ARTICUL 40MM M SPEC+8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 16, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 14, 2011
PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·June 13, 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