Data / Medical devices / Israel / Ivt Medical Ltd.
Ivt Medical Ltd.: FDA-registered device maker in Raanana Central, Israel, 1 510(k) clearance
Ivt Medical Ltd. is registered with the FDA (registration 3008320103) in Raanana Central, Israel. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 17, 2013. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008320103
- Address
- 16 Hatidhar St., Raanana Central, Israel, 4366518
- Owner or operator
- IVT Medical Ltd. (10031887)
- Roles
- Manufacturer
- First device listed
- March 18, 2010
- Registered through
- 2027
- Brand names listed
- Top Closure, TopClosure TopBase, TopClosure® 1S System, TopClosure® 1SAD, TopClosure® 1SM, TopClosure® 3S System, Vcare Alpha
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Manufacturer | accessdata.fda.gov |
| System, Skin Closure | MKY | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 17, 2013 | K121817 | VCARE A | OMP | Substantially Equivalent | IVT Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Skin Closure
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
Updated September 17, 2013. 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.