11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UltraClear Laser System (N/A)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551082553·Seeker, 45°, 20 cm
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
VASOBand Vascular Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·October 2, 2008
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 4, 2011
BD HUB CUTTER
FDA Adverse Event
Injury
·BD·Product code FOZ·July 16, 2013
SLIDE-LOCK ROT ATRAU GRASPER DBL-ACT 5MM-NA
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code HET·July 23, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025