Panels › Gastroenterology, Urology › Product code EZN · Class 2
Dilator, Catheter, Ureteral
Regulation 876.5470
0510(k)s in 12 months (56 all time)
0recalls in 12 months (14 all time)
14recalls that name a 510(k)
Top companies in EZN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2025 | Boston Scientific Corporation Boston Scientific UroMax Ultra Kit, Material Numbers (UPN):
1. M0062251200,
2. M0062251210,
3. M0062251220,
4. M0062251230,
5. M0062251240,
6. M0062251260,
7. M0062251290,
8. M0062251300,
9. Open, Classified |
EZN | K130804 |
| Apr 2, 2024 | Coloplast Manufacturing US, LLC Ureteral dilator, REF RBD014 Open, Classified |
EZN | K170531 |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | K061009 |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | K061009 |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | K061009 |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | K061009 |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | K061009 |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | K061009 |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | K061009 |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | K061009 |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | K061009 |
| Dec 3, 2005 | C.R. Bard, Inc., Urological Division Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO Terminated |
EZN | K993840 |
| Feb 13, 2003 | Cook Urological, Inc. Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0 Terminated |
EZN | K990072 |
| Feb 13, 2003 | Cook Urological, Inc. Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0 Terminated |
EZN | K990072 |
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