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U.S. Department of Health and Human Services

510(K) Premarket Notification

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101 to 110 of 498 Results
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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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dfp4343c7 Mdi Consultants, Inc. k122589 10/05/2012
avt naturasoft Advanced Vision Technologies k121324 08/23/2012
surgiclear antimicrobial clear silicone adhesive dressing with chlorhexidine and silver Covalontechnologies, Inc. k121819 08/13/2012
nexus tko-6, luer-activated device Nexus Medical, LLC k113398 04/18/2012
ids-isys igfbp-3 control set, ids-isys human growth hormone (hgh) calibration verifiers, and ids-isys igfbp-3 cal... Immunodiagnostic Systems , Ltd. k111938 02/14/2012
audit(r) microlq(tm) serum protein control Aalto Scientific, Ltd. k112705 01/24/2012
imagelink Computer Programs and Systems, Inc. k112096 09/30/2011
nexwave combo muscle stimulator system Zynex Medical, Inc. k111279 09/20/2011
abx pentra enzymatic creatinine cp, abx pentra multical, abx pentra n control, abx pentra p control, and abx pentra urin HORIBA ABX SAS k110137 08/10/2011
bel-cat Takara Belmont Corp. k101181 07/19/2011

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