7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OPUS(R) LH TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Revolution Ascend
FDA 510(k)
FDA Class 2
·Radiology
BALLOON SLG 14 FR X 1.2 CM 1CT/EA
FDA Adverse Event
Other
·COVIDIEN·Product code KNT·June 6, 2014
CORDLESS DRIVER 3
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·December 6, 2012
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·November 19, 2010
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013