8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
FDA 510(k)
FDA Class 2
·Hematology
Bioplate®
FDA UDI
Bioplate, Inc.·M3848133420·Compact Plus Kit ø1.9mm System
SOMATOM DEFINITION FLASH
FDA 510(k)
FDA Class 2
·Radiology
EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·FRANTZ MEDICAL DEVELOPMENT LTD.·Product code LZH·May 15, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
ARCHITECT I2000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·August 24, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015