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American Medical Systems, Inc.

10 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfa recall (Z-0805-2015)American Medical Systems, Inc.2014-12-16
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (no recall (Z-0806-2015)American Medical Systems, Inc.2014-12-16
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72 recall (Z-0209-2015)American Medical Systems, Inc.2014-11-13
AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinar recall (Z-1279-2013)American Medical Systems, Inc.2013-05-10
AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinar recall (Z-1280-2013)American Medical Systems, Inc.2013-05-10
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS recall (Z-0259-2013)American Medical Systems, Inc.2012-11-07
Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-0 recall (Z-2755-2011)American Medical Systems, Inc.2011-07-07
AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam, Americ recall (Z-2668-2011)American Medical Systems, Inc.2011-06-27
AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Steril recall (Z-2669-2011)American Medical Systems, Inc.2011-06-27
Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male recall (Z-0808-2011)American Medical Systems, Inc.2010-12-27

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Every clearance here is in the API, with alerts when new ones post.