Home › Device types › EZY
Device, Incontinence, Mechanical/Hydraulic
FDA product code EZY · Class 3 · Gastroenterology, Urology
35
Registered devices
18,298
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
AMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — AMERICAN MEDICAL SYSTEMS, INC.AMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — AMERICAN MEDICAL SYSTEMS, INC.AMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATIONAMS 800 Artificial Urinary Sphincter — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-28 | Boston Scientific Corporation | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 7240009 |
| 2024-10-28 | Boston Scientific Corporation | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 7240009 |
| 2021-11-22 | Uromedica Inc. | The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure. |
| 2019-07-19 | Boston Scientific Corporation | Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. |
| 2013-03-01 | American Medical Systems, Inc. | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control System, Control Pump & Pressure-Regulating Balloon. The |
| 2013-03-01 | American Medical Systems, Inc. | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control System, Control Pump & Pressure-Regulating Balloon. The |
| 2011-05-09 | American Medical Systems, Inc. | American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we |
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