15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XPERT FLU/RSV XC ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1420450·14mm H x 20mm W x 45mm L x 0 degrees XLIF
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741420450·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694043885·2.0mm Locking 3 x 3 Angle Plate, 2.0mm thick
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X142045120·14mm H x 20mm W x 45mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L142045120·14mm H x 20mm W x 45mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X14204580·14mm H x 20mm W x 45mm L x 8 degrees XLIF
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674142045060·
NXSTAGE PUREFLOW-B SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIMENSION VISA HBA1C, MODEL K3105A
FDA 510(k)
FDA Class 2
·Hematology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
IDRIVE ULTRA POWERED HANDLE 1
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·October 4, 2014
AU2700 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMAK.K.·Product code JGS·June 28, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024