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DELFI 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
LinkedIn: —
Facebook: —
Email: [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 4 of 4

Device	Model / Reference	Registries	Class	Status
Delfi Vari-Fit Tourniquet Cuff Single Use Dp Sb Contour Lower Leg With Matching Limb Protection Sleeve	60-9400-004-00	EUDAMEDFDA UDI	Class IIa	Active
Delfi Pedi-Fit Tourniquet Cuff Single Use Dp Sb Cylindrical P2.25 With Matching Limb Protection Sleeve	60-9800-002-00	EUDAMEDFDA UDI	Class IIa	Active
Delfi Vari-Fit Tourniquet Cuff Single Use Dual Port Single Bladder Contour Arm With Matching Limb Protection Sleeve	60-9400-002-00	EUDAMEDFDA UDI	Class IIa	Active
Delfi Pedi-Fit Tourniquet Cuff Single Use Sp Sb Cylindrical P2.25 With Matching Limb Protection Sleeve	60-9700-002-00	EUDAMEDFDA UDI	Class IIa	Active
Delfi Pedi-Fit Tourniquet Cuff Single Use Dual Port Single Bladder Cylindrical P1.5 With Matching Limb Protection Sleeve	60-9800-001-00	EUDAMEDFDA UDI	Class IIa	Active
Matching Limb Protection Sleeve Single Patient Multiple use	9-7955-024	EUDAMED	Class I	Active
Delfi Vari-Fit Tourniquet Cuff Single Use Dual Port Single Bladder Contour Thigh With Matching Limb Protection Sleeve	60-9400-003-00	EUDAMEDFDA UDI	Class IIa	Active
Delfi Pedi-Fit Tourniquet Cuff Single Use Sp Sb Cylindrical P3.5 With Matching Limb Protection Sleeve	60-9700-004-00	EUDAMEDFDA UDI	Class IIa	Active
PTS Personalized Tourniquet System for Blood Flow Restriction	9-2200-200BFR_M	EUDAMED	Class I	Active
Easi-Fit BFR, Single Port Contour Tourniquet Cuff	9-7555-024	EUDAMED	Class I	Active
Matching Limb Protection sleeve Single Use	9-7965-044	EUDAMED	Class I	Active
Delfi Vari-Fit Tourniquet Cuff Single Use Sp Sb Contour Lower Leg With Matching Limb Protection Sleeve	60-9300-004-00	EUDAMEDFDA UDI	Class IIa	Active
PTS Personalized Tourniquet System for Blood Flow Restriction	9-2500-400BFR_M	EUDAMED	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.