10 results
·
35ms
·
Sources: EU EUDAMED, US FDA
MANUAL MICRO ELISA READER #2-530
FDA 510(k)
FDA Class 1
·Clinical Chemistry
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551199985·Scissors, HM, curved, 14.5 cm
ELECTRONIC BLOOD PRESSURE UNIT
FDA 510(k)
FDA Class 2
·Cardiovascular
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 5, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·October 15, 2012
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·August 6, 2010
PALL ULTIPOR 25 BREATHING SYSTEM FILTER
FDA Adverse Event
Injury
·PALL NEWQUAY·Product code CAH·July 13, 2018
PALL ULTIPOR 100 BREATHING SYSTEM FILTER
FDA Adverse Event
Injury
·PALL NEWQUAY·Product code CAH·April 18, 2017
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025