10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RADIANALYZER XPRESS
FDA 510(k)
FDA Class 2
·Cardiovascular
GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 105mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665036725·
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
FDA 510(k)
FDA Class 2
·Cardiovascular
POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
TRIATHLON PS X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 3, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER-SILICON VALLEY·Product code GEX·April 6, 2011
PUMP MMT-512LNAP PRDGM INS PL EN US LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 31, 2008
NONIN
FDA Adverse Event
Other
·CAREFUSION 211, INC.·Product code DQA·December 13, 2010
Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.
FDA Recall
Terminated
·Varian Medical Systems·Product code JAQ·April 14, 2005
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
FDA Enforcement
Class III
·Terminated·Advanced Sterilization Products·December 11, 2013