15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SR ADORO
FDA 510(k)
FDA Class 2
·Dental
ALGO 5
FDA UDI
Natus Medical Denmark ApS·05713315012204·A5 LASER PRINTER
LUXAFORM
FDA 510(k)
FDA Class 2
·Dental
ISLAND WOUND DRESSING WITH MICROBAN
FDA 510(k)
FDA Unclassified
·Unknown
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 8, 2013
SHILEY LOW PRESSURE CUFFED
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·March 25, 2011
ACCU-CHEK INFORM METER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·May 2, 2008
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019
HUIBREGTSE NEEDLE KNIFE PAPILLOTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·July 19, 2022
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019
COBAS® MPX - 96T
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 24, 2025
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018