Panels › Gastroenterology, Urology › Product code EZY · Class 3
Device, Incontinence, Mechanical/Hydraulic
Regulation 876.5280
0510(k)s in 12 months (0 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in EZY
| Company | 510(k)s | Recalls |
|---|---|---|
| American Medical Systems, Inc. | 0 | 3 |
| Boston Scientific Corporation | 0 | 3 |
| Uromedica Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2024 | Boston Scientific Corporation AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O Open, Classified |
EZY | None listed |
| Nov 25, 2024 | Boston Scientific Corporation AMS Artificial Urinary Sphincter Control Pump Open, Classified |
EZY | None listed |
| Nov 22, 2021 | Uromedica Inc. UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile. Terminated |
EZY | None listed |
| Jul 19, 2019 | Boston Scientific Corporation AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm
Part Number: 72400161 Terminated |
EZY | None listed |
| May 10, 2013 | American Medical Systems, Inc. AMS 800 Urinary Control System.
The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. Terminated |
EZY | None listed |
| May 10, 2013 | American Medical Systems, Inc. AMS 800 Urinary Control System.
The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery Terminated |
EZY | None listed |
| Jun 27, 2011 | American Medical Systems, Inc. AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343
InhibiZone Terminated |
EZY | None listed |
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