9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FRUCTOSAMINE ABG21 TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613025649·Operating Scissors, Straight, Sharp/Blunt Tipd,...
TROJAN CRYSTAL CLEAR LIQUID
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DRILL F.RADIOLUCENT TARGETING DEVICE SIDEWINDER Ø3,2 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·September 16, 2013
RAPID 1265
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code GIG·January 3, 2013
RECONSTITUTION DEVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code LHI·December 3, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 3, 2014
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