14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741314450·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674131445060·
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605046·SPACER 2131445 OLIF25 27MM 6 DEG 14X45
Special
FDA UDI
Seaspine Orthopedics Corporation·10889981332020·Firefly Tap, 4.5mm
VITAL SIGNS MONITOR-VSM 6000 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
MAINLINE MAXIE HCG URINE PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
STEALTHSTATION® S7´
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019
PELVICOL ACELLULAR COLLAGEN MATRIC 4X7CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 10, 2013
ACUITY
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code OJX·October 1, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015