8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Guided Surgery Kit Cases
FDA 510(k)
FDA Class 2
·General Hospital
K041492
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 18, 2021
ASTRA TECH IMPLANTS - DENTAL SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 9, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 22, 2013