Data / Medical devices / Israel / Medisim Ltd.
Medisim Ltd.: FDA-registered device maker in Ness Ziona Central, Israel, 6 510(k) clearances
Medisim Ltd. is registered with the FDA (registration 9616787) in Ness Ziona Central, Israel. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated October 20, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616787
- FEI number
- 3006654321
- Address
- 5 Professor Avraham Patchornik Street 6th Floor, Building A, Ness Ziona Central, Israel, 7413014
- Owner or operator
- MEDISIM LTD. (9035477)
- Roles
- Complaint file establishment, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 13, 2008
- Registered through
- 2026
- Brand names listed
- FHT1- Temple Touch Mini, FHT2 - Temple Touch Premium, FHT5, FHT6, FHT7, Forehead THEROMETER, M5T - 3 Way Thermometer, Mother's touch and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| October 20, 2015 | K150160 | Temple Touch Pro (TTP) Non-invasive temperature monitoring system | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
| August 28, 2013 | K131155 | UGFT3; FHT7 | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
| September 1, 2005 | K051422 | DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
| December 4, 2003 | K032362 | UP-GRADE FOREHEAD THERMOMETER | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
| August 1, 2001 | K012217 | M5T INSTANT FEVER THERMOMETER | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
| February 12, 1999 | K983887 | UP-GRADE AND UP-GRADE PRO | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 20, 2015. 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.