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American Medical Systems

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen recall (Z-0932-2009)American Medical Systems2009-01-27
AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668 recall (Z-2461-2008)American Medical Systems2008-09-20
AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladde recall (Z-1235-2008)American Medical Systems2008-07-16
AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, produ recall (Z-0785-2007)American Medical Systems2007-05-09
AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, product length 18 cm, product number recall (Z-0786-2007)American Medical Systems2007-05-09
AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product n recall (Z-0787-2007)American Medical Systems2007-05-09
AMS 700 CX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm recall (Z-0788-2007)American Medical Systems2007-05-09
AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 c recall (Z-0789-2007)American Medical Systems2007-05-09
AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, recall (Z-0702-2007)American Medical Systems2007-04-03
AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical System recall (Z-0703-2007)American Medical Systems2007-04-03
her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: Am recall (Z-0675-06)American Medical Systems2006-03-23
Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 recall (Z-1019-04)American Medical Systems2004-07-20

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