Data / Medical devices / Israel / Medinol Ltd.
Medinol Ltd.: FDA-registered device maker in TEL-AVIV Tel Aviv, Israel, 3 510(k) clearances and 1 PMA approval
Medinol Ltd. is registered with the FDA (registration 9710284) in TEL-AVIV Tel Aviv, Israel. It lists 3 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated January 25, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9710284
- FEI number
- 3003084171
- Address
- Kiryat Atidim, BLDG. 8, TEL-AVIV Tel Aviv, Israel, 6158101
- Owner or operator
- MEDINOL LTD. (9031416)
- Roles
- Specification developer
- First device listed
- March 23, 2009
- Registered through
- 2027
- Brand names listed
- EluNIR Ridaforolimus Eluting Coronary Stent System, Gallant PTCA Dilatation Catheter, NC Gallant PTCA Dilatation Catheter, X-Suit NIR® Biliary Metallic Stent
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Specification developer | accessdata.fda.gov |
| Coronary Drug-Eluting Stent | NIQ | 3 | Specification developer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 25, 2018 | K173581 | Gallant PTCA Dilatation Catheter | LOX | Substantially Equivalent | Medinol, Ltd. | accessdata.fda.gov |
| January 19, 2017 | K162434 | NC Gallant PTCA Catheter | LOX | Substantially Equivalent | Medinol, Ltd. | accessdata.fda.gov |
| January 9, 2009 | K081956 | MEDINOL X-SUIT NIR BILIARY METALLIC STENT | FGE | Unknown | Medinol, Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 28, 2017 | P170008 | EluNIR Ridaforolimus Eluting Coronary Stent System | NIQ | 54 | August 6, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Coronary Drug-Eluting Stent
Updated August 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.