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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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rubicor encapsule breast biopsy device, model 30086 RUBICOR MEDICAL, INC. k023601 11/19/2002
reprocessed electrophysiology diagnostic catheters STERILMED, INC. k092158 01/14/2010
replus dental implants (ha) IMPLANT DIRECT LLC k073161 03/07/2008
rc loop /dual orthocord suture,rc loop w/ethibond suture,rc loop w/panacryl suture DEPUY MITEK, A JOHNSON & JOHNSON COMPANY k060553 05/04/2006
raichem ldl-cholesterol direct reagent HEMAGEN DIAGNOSTICS, INC. k022772 09/17/2002
radiodexter, dextroscope, dextrobeam, models 1.0, mk10, mk3 & mk4 VOLUME INTERACTIONS PTE LTD k071054 05/22/2007
rabea spinal implant SIGNUS MEDIZINTECHNIK GMBH k043316 02/07/2005
qwiklead reusable electrocardiograph electrode patch CARDIAC LEAD TECHNOLOGIES, INC. k090496 09/01/2009
quickvue influenza a+b test QUIDEL CORP. k092698 09/15/2009
quantix/or blood flow monitor; flexible probe with optional vessel stabilizer NEOPROBE CORP. k050088 02/08/2005

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