Medical Compression Systems (Dbn) , Ltd.
Medical Compression Systems (Dbn) , Ltd. has 0 FDA recalls, 2 inspections, 10 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Jul 11, 2012 · NAI
- Latest 510(k)
- Jul 13, 2016
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 10 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 11, 2012 | Or Akiva, Israel | Devices | No Action Indicated (NAI) | 3003715046 |
| Jun 23, 2011 | Or Akiva, Israel | Devices | Official Action Indicated (OAI) | 3003715046 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Medical Compression Systems (Dbn) , Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003715046 | Or Akiva, Israel | 2 | Jul 11, 2012 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K160431 | ActiveCare Home | Jul 13, 2016 |
| K140755 | ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS | May 8, 2014 |
| K113525 | ACTIVECARE DVT ACTIVECARE+SFT | Jan 31, 2012 |
| K110159 | ACTIVECARE SFT | May 12, 2011 |
| K060146 | ACTIVECARE ++ SYSTEM | Mar 8, 2006 |
| K023573 | WIZAIR COMPRESSION SYSTEM | Nov 21, 2002 |
| K012994 | WIZAIR DVT | Mar 27, 2002 |
| K002287 | WIZAIR COMPRESSION SYSTEM | Aug 25, 2000 |
| K993758 | PROAIR 3000 COMPRESSION SYSTEM | May 19, 2000 |
| K994057 | SLENDAIR 4000 COMPRESSION SYSTEM | Mar 3, 2000 |
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