American Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 82
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0805-2015 | Class II | AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hamm | October 15, 2014 |
| Z-0806-2015 | Class II | AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commer | October 15, 2014 |
| Z-0209-2015 | Class II | AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. | October 10, 2014 |
| Z-1280-2013 | Class II | AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary in | March 1, 2013 |
| Z-1279-2013 | Class II | AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary i | March 1, 2013 |
| Z-0259-2013 | Class II | AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance | October 19, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140679 | SUREFLEX LITHOTRIPSY LASER FIBERS | June 20, 2014 |
| K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | December 5, 2013 |
| K132655 | RETROARC RETROPUBIC SLING SYSTEM | November 20, 2013 |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | October 16, 2012 |
| K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM | September 7, 2012 |
| K121612 | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION | July 20, 2012 |
| K120870 | GREENLIGHT MOXY FIBER OPTIC | June 15, 2012 |
| K112842 | AMS ELEVATE PC | October 25, 2011 |
| K111118 | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO L | July 1, 2011 |
| K100746 | FIBER ONE | June 11, 2010 |
| K100807 | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 | June 7, 2010 |
| K092735 | GREENLIGHT XPS LASER SYSTEM | November 9, 2009 |
| K090934 | PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM | June 2, 2009 |
| K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | April 9, 2009 |
| K090713 | ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYS | April 2, 2009 |
| K082677 | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | December 23, 2008 |
| K082387 | APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SY | December 4, 2008 |
| K082730 | AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND PO | November 26, 2008 |
| K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | October 20, 2008 |
| K081710 | APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE | October 15, 2008 |