13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STITCHKIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CASCADIA™ Interbody System
FDA UDI
VB Spine LLC·10888857554658·Trial Size 16x20x6 mm, Convex
BD¿ ULTRA-FINE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 15, 2018
V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO VIABAHN ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 23, 2024
HAHN TAPERED IMPLANT Ø5.0 X 8MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 26, 2023
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 17, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
2520274-2013-02685
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·May 22, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
PULSE GEN MODEL 101
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 15, 2008
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023