Data / Medical devices / Israel / Medical Systems And Devices International Ltd.
Medical Systems And Devices International Ltd.: FDA-registered device maker in Kiryat Ata Haifa, Israel, 1 510(k) clearance
Medical Systems And Devices International Ltd. is registered with the FDA (registration 3013167159) in Kiryat Ata Haifa, Israel. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 26, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013167159
- Address
- Derech Haifa 37, Kiryat Ata, P.O Box 25414, Kiryat Ata Haifa, Israel, 2822639
- Owner or operator
- Medical Systems and Devices International Ltd. (10059177)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 9, 2018
- Registered through
- 2026
- Brand names listed
- Alef, Kaf, Taf MSDI Dental Implants System, Attachments, precision attachment, Dental Accessories, MSDI Dental Tools
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | 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 |
|---|---|---|---|---|---|---|
| June 26, 2020 | K191443 | MSDI Dental Implants System | DZE | Substantially Equivalent | Medical Systems and Devices International , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Handle, Instrument, Dental
- All makers of Attachment, Precision, All
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
Updated June 26, 2020. 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.