Medical Electronic Systems Ltd.
CAESAREA IND. PARK Haifa, IL
MEDICAL ELECTRONIC SYSTEMS LTD. appears in FDA device records in CAESAREA IND. PARK Haifa, IL. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. 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 7 510(k) clearances for Medical Electronic Systems Ltd. between 2001 and 2025. The busiest year on record is 2001, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2007 | 1 |
| 2016 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243114 | SQA-iOw Sperm Quality Analyzer | POV | Substantially Equivalent | |
| K241628 | YO Home Sperm Test | POV | Substantially Equivalent | |
| K220828 | SQA-iO Sperm Quality Analyzer | POV | Substantially Equivalent | |
| K161493 | YO Home Sperm Test | POV | Substantially Equivalent | |
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | POV | Substantially Equivalent | |
| K021746 | SQA V, SPERM QUALITY ANALYZER | POV | Substantially Equivalent | |
| K012352 | SQA, SPERM QUALITY ANALYZER | POV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003646592 | 3003646592 | MEDICAL ELECTRONIC SYSTEMS LTD. | ALON HATAVOR ST. 20 ZONE 6, CAESAREA IND. PARK Haifa 3088900 IL | 2026 | |
| 3005831224 | 3005831224 | MEDICAL ELECTRONIC SYSTEMS, LLC | 6345 Balboa Blvd, Unit #185, Encino, CA 91316 US | 2026 | No device listings on this registration |
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