14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Plateau-V Spacer System
FDA UDI
Life Spine, Inc.·00190837029159·PLATEAU-V Interbody, Straight, Bulleted, 12mm x...
BD INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 2, 2019
NMI COAXIAL MICROINTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
FDA 510(k)
FDA Class 2
·Microbiology
BD SYRINGE 0.3ML 31GA 8MM 10BAG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 31, 2019
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 12, 2024
SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·August 9, 2019
SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 19, 2019
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code NIQ·June 9, 2006
MIC-KEY LOW-PROFILE GASTROSTOMY TUBE
FDA Adverse Event
Malfunction
·AVENT SA DE R.L. DE C.V.·Product code KNT·November 14, 2008
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 19, 2011
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025