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FDA 510(k) Applications Submitted by AMERICAN MEDICAL SYSTEMS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100746
03/16/2010
FIBER ONE
AMERICAN MEDICAL SYSTEMS
K081710
06/17/2008
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
AMERICAN MEDICAL SYSTEMS
K120870
03/22/2012
GREENLIGHT MOXY FIBER OPTIC
AMERICAN MEDICAL SYSTEMS
K140679
03/18/2014
SUREFLEX LITHOTRIPSY LASER FIBERS
AMERICAN MEDICAL SYSTEMS
K111118
04/21/2011
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
AMERICAN MEDICAL SYSTEMS
K121612
06/01/2012
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
AMERICAN MEDICAL SYSTEMS
K121641
06/04/2012
MINIARC PRO SINGLE-INCISION SLING SYSTEM
AMERICAN MEDICAL SYSTEMS
K121805
06/19/2012
AMS LARGE PORE POLYPROPHLENE MESH
AMERICAN MEDICAL SYSTEMS
K082387
08/19/2008
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
AMERICAN MEDICAL SYSTEMS
K131229
04/30/2013
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
AMERICAN MEDICAL SYSTEMS
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