American Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: RETROARC RETROPUBIC SLING SYSTEM, AMS ELEVATE PC, MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
72
Total
72
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Medical Systems, Inc. Gastroenterology & Urology ✕
45 devices
Cleared
Nov 20, 2013
RETROARC RETROPUBIC SLING SYSTEM
Gastroenterology & Urology
86d
Cleared
Jun 07, 2010
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
Gastroenterology & Urology
77d
Cleared
Apr 09, 2009
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Gastroenterology & Urology
28d
Cleared
Oct 20, 2008
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Gastroenterology & Urology
97d
Cleared
Sep 17, 2008
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
Gastroenterology & Urology
100d
Cleared
Jan 30, 2008
AMS MINIARC SLING SYSTEM
Gastroenterology & Urology
30d
Cleared
Aug 24, 2007
AMS MINIARC SLING SYSTEM
Gastroenterology & Urology
45d
Cleared
Mar 01, 2007
AMS SINGLE INCISION SLING SYSTEM (SIS-0)
Gastroenterology & Urology
52d
Cleared
Feb 22, 2007
AMS SMART SLING SYSTEM
Gastroenterology & Urology
70d
Cleared
Feb 03, 2006
AMS MALE TRANSOBTURATOR SLING SYSTEM
Gastroenterology & Urology
60d
Cleared
Jul 08, 2005
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193
Gastroenterology & Urology
29d
Cleared
Dec 14, 2004
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
Gastroenterology & Urology
82d
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