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Sign in to claim this brandDELFI MEDICAL INNOVATIONS INC.
Canada·CA-MF-000004434
Last updated September 17, 2026
Information
- Country
- Canada
- Address
- 1099, West 8th Avenue, Vancouver, Canada
- Website
- www.delfimedical.com
- —
- —
- [email protected]
- Phone
- +1 604 742 0600
- PRRC Contact
- Robert MacNeil
- EUDAMED SRN
- CA-MF-000004434
- FDA FEI Number
- 3003748933
- DUNS Number
- —
Catalogue (163)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Matching Limb Protection Sleeves - Easi-Fit BFR | 9-7950-300 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Petite-Fit | 9-7910-002 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Vari-Fit | 60-7920-003-00 | FDA UDI | Class I | Active |
| Petite-Fit (Small Adult), Reusable | 60-8000-002-00 | FDA UDI | Class I | Active |
| Pedi-Fit Sterile Single Use | 9-9800-003 | FDA UDI | Class I | Active |
| Pedi-Fit Sterile Single Use | 9-9800-002 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Easi-Fit BFR | 9-7960-018 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 9-7450-002 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Easi-Fit BFR | 9-7950-024 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 60-7450-002-00 | FDA UDI | Class I | Active |
| Easi-Fit Reusable | 9-7600-034 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 9-7350-004 | FDA UDI | Class I | Active |
| PTSii Personalized Tourniquet System Kit, Single | 9-2200-450 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 9-7450-003 | FDA UDI | Class I | Active |
| Sterile Disposable Contour Cuff | 60-7975-104-00 | FDA UDI | Class I | Active |
| PTSii Personalized Tourniquet System Kit, Twin | 9-2200-400 | FDA UDI | Class I | Active |
| Sterile Disposable Contour Cuff | 60-7975-154-00 | FDA UDI | Class I | Active |
| Petite-Fit (Small Adult), Reusable | 60-8100-001-00 | FDA UDI | Class I | Active |
| Easi-Fit BFR, Reusable | 9-7550-018 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Vari-Fit | 60-7920-002-00 | FDA UDI | Class I | Active |
| Vari-Fit Sterile Single Use | 9-9300-011 | FDA UDI | Class I | Active |
| Pedi-Fit Sterile Single Use | 9-9700-003 | FDA UDI | Class I | Active |
| Vari-Fit Sterile Single Use | 9-9300-002 | FDA UDI | Class I | Active |
| Easi-Fit Reusable | 9-7600-018 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 9-7350-005 | FDA UDI | Class I | Active |
| Easi-Fit Reusable | 9-7500-024 | FDA UDI | Class I | Active |
| Easi-Fit Reusable | 9-7500-044 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Petite-Fit | 60-7910-002-00 | FDA UDI | Class I | Active |
| Sterile Disposable Contour Cuff | 60-7970-157-00 | FDA UDI | Class I | Active |
| Vari-Fit Sterile Single Use | 9-9300-004 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Petite-Fit | 60-7910-001-00 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 60-7450-011-00 | FDA UDI | Class I | Active |
| Easi-Fit Reusable | 9-7600-044 | FDA UDI | Class I | Active |
| Pedi-Fit Reusable | 9-7700-004 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 9-7350-002 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Vari-Fit | 9-7920-003 | FDA UDI | Class I | Active |
| Pedi-Fit Sterile Single Use | 9-9800-001 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 60-7450-004-00 | FDA UDI | Class I | Active |
| Sterile Disposable Contour Cuff | 60-7975-156-00 | FDA UDI | Class I | Active |
| Pedi-Fit Reusable | 9-7800-002 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Easi-Fit | 9-7920-018 | FDA UDI | Class I | Active |
| Matching Limb Protection Sleeves - Easi-Fit | 9-7920-052 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 9-7450-004 | FDA UDI | Class I | Active |
| Easi-Fit Reusable | 9-7500-018 | FDA UDI | Class I | Active |
| Easi-Fit BFR, Reusable | 9-7550-024 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 9-7450-005 | FDA UDI | Class I | Active |
| Vari-Fit Reusable | 60-7350-011-00 | FDA UDI | Class I | Active |
| Petite-Fit (Small Adult), Reusable | 9-8100-002 | FDA UDI | Class I | Active |
| PTS Transport Bag | 9-2200-310 | FDA UDI | Class I | Active |
| Pedi-Fit Reusable | 9-7700-002 | FDA UDI | Class I | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 3, 2019 | Z-1902-2020 | — | terminated | Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff. |
| Apr 3, 2019 | Z-1901-2020 | — | terminated | Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff. |