10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DeepContour (V1.0)
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·December 27, 2019
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
FDA 510(k)
FDA Class 2
·Neurology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 2, 2011
STERRAD 200 STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 18, 2013
UNIVERSAL CHUCK WITH T-HANDLE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·June 11, 2019
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025