8 results
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20ms
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Sources: EU EUDAMED, US FDA
REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
FDA 510(k)
FDA Class 2
·Anesthesiology
Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 27, 2016
4CIS® Pinehurst Anterior Cervical Plate system
FDA 510(k)
FDA Class 2
·Orthopedic
REIGNING CROWN BRIDGE
FDA 510(k)
FDA Class 2
·Dental
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2014
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·October 21, 2010
2.7MM/3.5MM TI VA-LCP LAT DSTLHUMERUS PL 1H/LT/69MM-SHORT
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·December 20, 2012
Neurosurgery Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015