10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSSIX Breeze
FDA 510(k)
FDA Class 2
·Dental
Philips
FDA UDI
Sbo Hearing A/S·05714464003419·HEARLINK 9010 BTE PP, 2.4G NFM DPB BL
TRIMED CLAVICLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OVERJET CARIES ASSIST
FDA Adverse Event
Malfunction
·OVERJET·Product code MYN·February 18, 2025
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
ASEPTICO ENDO DTC
FDA Adverse Event
Malfunction
·DENTSPLY TULSA DENTAL SPECIALTIES·Product code GEY·October 27, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023