Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

73 results for "American Medical Systems, Inc."
1–24 of 73
Search insights Median review: 70d Cleared: 100% Top manufacturer: American Medical Systems, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 29, 2015
Ultimax-i
K143281 · OWB
Toshibamedical Systems Corporation
Radiology · 76d
Cleared Nov 20, 2013
RETROARC RETROPUBIC SLING SYSTEM
K132655 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 86d
Cleared Oct 25, 2011
AMS ELEVATE PC
K112842 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 26d
Cleared Jun 07, 2010
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
K100807 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 09, 2009
GREENLIGHT XPS LASER SYSTEM
K092735 · GEX
American Medical Systems, Inc.
General & Plastic Surgery · 66d
Cleared Jun 02, 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
K090934 · FTL
American Medical Systems, Inc.
General & Plastic Surgery · 61d
Cleared Apr 09, 2009
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K090663 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 02, 2009
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND...
K090713 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 15d
Cleared Dec 23, 2008
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K082677 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 99d
Cleared Nov 26, 2008
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE,...
K082730 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 69d
Cleared Oct 20, 2008
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K082006 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 97d
Cleared Sep 17, 2008
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
K081613 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 100d
Cleared Apr 10, 2008
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH...
K080185 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 76d
Cleared Apr 10, 2008
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL...
K073219 · FTM
American Medical Systems, Inc.
General & Plastic Surgery · 147d
Cleared Jan 30, 2008
AMS MINIARC SLING SYSTEM
K073703 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 24, 2007
AMS MINIARC SLING SYSTEM
K071902 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 45d
Cleared May 09, 2007
TOPAS SYSTEM
K070993 · FTL
American Medical Systems, Inc.
General & Plastic Surgery · 30d
Cleared Mar 01, 2007
AMS SINGLE INCISION SLING SYSTEM (SIS-0)
K070065 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 22, 2007
AMS SMART SLING SYSTEM
K063713 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Feb 03, 2006
AMS MALE TRANSOBTURATOR SLING SYSTEM
K053371 · OTM
American Medical Systems, Inc.
Gastroenterology & Urology · 60d
Cleared Aug 03, 2005
AMS PELVIC FLOOR REPAIR SYSTEM
K051485 · OTO
American Medical Systems, Inc.
Obstetrics & Gynecology · 58d
Cleared Jul 08, 2005
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193
K051530 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 17, 2005
AMS COLLAGEN DERMAL MATRIX
K050445 · PAG
American Medical Systems, Inc.
General & Plastic Surgery · 115d
Cleared Dec 14, 2004
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
K042592 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 82d