13 results
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22ms
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Sources: EU EUDAMED, US FDA
TRIPOD
FDA 510(k)
FDA Class 1
·Physical Medicine
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P0609260·6mm PLIF Implant 9mm Wide 16mm Length
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609261·Mini Sprint-Brackets Roth .022" 20 Brackets
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P06092670·6mm PLIF Implant 9mm Wide 26mm Length, 7 deg Lo...
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
R-SI-LINE METAL-BITE
FDA 510(k)
FDA Class 2
·Dental
TERUMO CENTRIFUGAL SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·April 10, 2013
AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 14, 2011
GIA 80-3.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·June 13, 2008
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
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