9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
FDA 510(k)
FDA Class 2
·Dental
devemed
FDA UDI
devemed GmbH·04061644023691·Suction cannula Ø 4.0mm | 17.3cm
with hole
fron...
Reicodent
FDA UDI
devemed GmbH·04061644050185·Suction cannula Ø 4.0mm | 17.3cm
with hole
fron...
ISC-1000 PENTAX CONFOCAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ziehm Vision RFD 3D
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025