9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MINIATURE ION SELECTIVE ELECTRODES
FDA 510(k)
FDA Class 1
·Microbiology
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435061783·MCD Screw 3.0 x 30 mm M2
lockin...
ATG/SM-OSA APPLIANCES
FDA 510(k)
FDA Class 2
·Dental
Micromate Navi+
FDA 510(k)
FDA Class 2
·Radiology
LANDMARX EVOLUTION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 23, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 13, 2012
EVERA XT VR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LWS·June 10, 2015
ERYTYPECELL A1 & B
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·May 16, 2019
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025