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."
49–72 of 73
Search insights Median review: 70d Cleared: 100% Top manufacturer: American Medical Systems, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 04, 1996
AMS AMBICOR PENILE PROSTHESIS
K963328 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 103d
Cleared Jul 06, 1995
AMS 650 MALLERABLE PENIEL PROSTHESIS
K951716 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 19, 1994
ENTRAC URETERAL BALLOON DILATATION CATHETERS
K942578 · EZN
American Medical Systems, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 18, 1994
NAMIC ARIA(TM) INFLATION DEVICE
K940542 · EZN
American Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Oct 28, 1992
ENTRAC URETERAL BALLOON DILATION CATHETERS
K921839 · EZN
American Medical Systems, Inc.
Gastroenterology & Urology · 194d
Cleared Oct 28, 1992
120 FR OPTILUME PROSTATE BALLOON DILATOR
K920551 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 265d
Cleared May 06, 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
K920711 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Mar 20, 1992
ENTRAC(TM) URETHRAL MEASURING CATHETER
K914905 · GBM
American Medical Systems, Inc.
Gastroenterology & Urology · 140d
Cleared Mar 18, 1992
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
K912935 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 257d
Cleared Mar 18, 1992
AMS SPHINCTER 800 URINARY PROSTHESIS
K912934 · FAG
American Medical Systems, Inc.
Gastroenterology & Urology · 257d
Cleared Jun 27, 1990
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
K901482 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 17, 1990
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 17, 1990
AMS OPTILUME INFLATION SYRINGE
K900760 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 06, 1990
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
K896941 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 83d
Cleared Jun 17, 1988
1/2 CM REAR TIP EXTENDER (RTE)
K882297 · FHN
American Medical Systems, Inc.
Gastroenterology & Urology · 15d
Cleared Sep 05, 1985
URETERAL STENT
K852389 · FAD
American Medical Systems, Inc.
Gastroenterology & Urology · 92d
Cleared Jan 30, 1984
VERIFORM II
K833583 · DXN
American Medical Systems, Inc.
Cardiovascular · 110d
Cleared Aug 08, 1983
AMS MALLEABLE PENILE PROSTHESIS
K831660 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 77d
Cleared Apr 12, 1983
INFLATABLE PENILE PROSTH. - CYLINDER
K830048 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 92d
Cleared Aug 10, 1982
THE INFLATABLE PENILE PROSTHESIS
K821628 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Aug 10, 1982
THE ARTIFICIAL URINARY SPHINCTER
K821627 · FAG
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Jul 30, 1982
TOMAC LUBRICATING JELLY
K822143 · KMJ
American Medical Systems, Inc.
General Hospital · 9d
Cleared Apr 29, 1982
THERMO-K
K820814 · DWJ
American Medical Systems, Inc.
Cardiovascular · 36d
Cleared Sep 09, 1980
AMS MALLEABLE OR JONAS SILICONE-SILVER
K792724 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 253d