7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151
FDA 510(k)
FDA Class 1
·Hematology
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
HEALTH MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·June 12, 2014
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·December 12, 2012
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 6, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015