9 results
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26ms
·
Sources: EU EUDAMED, US FDA
SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT
FDA 510(k)
FDA Class 2
·Anesthesiology
TITANIUM MINI FRAGMENT SYSTEM1.5MM CONDYLAR PLATE - RIGHT
FDA UDI
Biomet Orthopedics, LLC·00887868053313·
TITANIUM MINI FRAGMENT SYSTEM2.0MM CONDYLAR PLATE - RIGHT
FDA UDI
Biomet Orthopedics, LLC·00887868053320·
COAT-A-COUNT ESTRADIOL KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROTOPATH FACTOR VIII ASSAY
FDA 510(k)
FDA Class 2
·Hematology
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 2, 2014
POWERED PATIENT ROTATION BED
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code IKZ·November 24, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·June 12, 2015
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