Smart Medical Systems Ltd.
Raanana Central, IL
SMART MEDICAL SYSTEMS LTD. appears in FDA device records in Raanana Central, IL. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Smart Medical Systems Ltd. between 2006 and 2022. The busiest year on record is 2010, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 1 |
| 2020 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220158 | G-EYE System | FDF | Substantially Equivalent | |
| K202469 | G-EYE System | FDF | Substantially Equivalent | |
| K192588 | G-EYE System | FDF | Substantially Equivalent | |
| K112106 | NAVIAID ICVI-F,S,B,R DEVICE | ODC | Substantially Equivalent | |
| K111760 | NAVIAID(TM) BGC DEVICE | ODC | Substantially Equivalent | |
| K110291 | NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE | ODC | Substantially Equivalent | |
| K102616 | NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE | FDF | Substantially Equivalent | |
| K101191 | NAVIAID ICVI DEVICE | FDF | Substantially Equivalent | |
| K060923 | NAVIAID BGE DEVICE, MODEL 21-001 | FDA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005261802 | 3005261802 | SMART MEDICAL SYSTEMS LTD. | 5 Hanofar Str., Raanana Central 4366404 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain