10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PHOENIX DIGITAL EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327623697·2.9X12.5MM DRILL, HARD BONE, HIP
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327623765·2.9X15.5MM DRILL, HARD BONE
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327623772·2.9X12.5MM DRILL, HARD BONE
DEVILBISS 9000 SERIES CPAP, MODEL 9001
FDA 510(k)
FDA Class 2
·Anesthesiology
JETSTREAM G3 (R) SF 1.6 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·November 30, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 2, 2014
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 11, 2012
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