11 results
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20ms
·
Sources: EU EUDAMED, US FDA
OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE
FDA 510(k)
FDA Class 2
·Neurology
TriMed Elbow and Forearm System
FDA 510(k)
FDA Class 2
·Orthopedic
PYR BROTH
FDA 510(k)
FDA Class 1
·Microbiology
UNK CAPIOX ARTERIAL FILTER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTM·April 8, 2019
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·February 5, 2013
IAB: 8 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·December 3, 2010
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 18, 2014
CAPIOX ARTERIAL FILTER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTM·October 10, 2018
ARTERIAL FILTER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTM·June 28, 2019
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026