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Sign in to claim this brandExelint International, Co.
United States·US-MF-000037396
Last updated September 17, 2026
What Exelint International, Co. makes
Exelint International, Co. manufactures single-use medical devices including hypodermic needles, manual scalpel blades, dermal curettes, and scalpels. Their product portfolio also includes disposable syringes, injection plugs, IV sets, IV cannulas with injection ports, biopsy punches, and anesthesia sets.
The company's devices are classified as Class I, Class II, Class III, and Class IIa, and are listed in the EUDAMED and FDA 510(k) registries. Exelint International, Co. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What medical devices does Exelint International, Co. manufacture?
Exelint International, Co. produces single-use medical devices including hypodermic needles, manual scalpel blades, dermal curettes, scalpels, disposable syringes, injection plugs, IV sets, IV cannulas with injection ports, biopsy punches, and anesthesia sets.
Where is Exelint International, Co. based?
Exelint International, Co. is based in the United States, as indicated in the provided device data.
Which regulatory registries list Exelint International, Co.'s devices?
Exelint International, Co.'s devices are listed in the EUDAMED and FDA 510(k) registries, as specified in the device data.
How are Exelint International, Co.'s devices classified?
Exelint International, Co.'s devices are classified as Class I, Class II, Class III, and Class IIa, according to the regulatory classifications provided in the device data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 2500, Santa Fe Ave., Redondo Beach, United States
- Website
- www.exelmedintl.com
- facebook.com/exelintinternational
- [email protected]
- Phone
- +1-310-649-0707
- PRRC Contact
- Vu Doan
- EUDAMED SRN
- US-MF-000037396
- FDA FEI Number
- 1035907
- DUNS Number
- —
Catalogue (312)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Exel Biopsy Punch, Ss, 7.0mm | 29569 | EUDAMEDFDA UDI | Class IIa | Active |
| EXEL 2-3mL SYR ONLY L-L | 26200 | EUDAMEDFDA UDI | Class I | Active |
| EXEL 1/2mL INS 28GX1/2" | 26032 | EUDAMEDFDA UDI | Class IIa | Active |
| EXEL Aluminum Hub Needles 18G X 5/8" | 26463B | EUDAMEDFDA UDI | Class IIa | Active |
| Exel Psv/M-S, L-A 23gx3/4" | 26766 | EUDAMED | Class IIa | Active |
| EXEL AmLUJECT DENTAL NDL. 27G X 21MM SHORT | JP-MF-000026759 | EUDAMEDFDA UDI | Class IIa | Active |
| EXEL Hypodermic Needle 25G x 5/8" | 26403 | EUDAMED | Class IIa | Active |
| Exel, Exeflon 22g Iv Cannula W/ Injection Port | 26596 | EUDAMED | Class IIa | Active |
| Exel Dermal Curette, Ss, 7.0mm | 29584 | EUDAMEDFDA UDI | Class IIa | Active |
| EXEL 2-3mL AMBER SYR ONLY L-L W/ TIP CAP | 26209 | EUDAMEDFDA UDI | Class I | Active |
| Exel, Exeflon 17g Iv Cannula W/ Injection Port | 26523 | EUDAMED | Class IIa | Active |
| EXEL 2-3mL SYR 18GX1-1/2" | 26110 | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Exelint International, Co. has 3 recall records, all initiated on 2009-12-23 and terminated. The recalls were for non-coring needles that were shown to core the silicone port's septum, which may lead to decreased effectiveness of the port, infection, necrosis, swelling, and embolization, potentially resulting in pulmonary embolism, limb ischemia, stroke, or local extravasation of medication.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 23, 2009 | Z-0638-2010 | — | terminated | Non-coring needles that, when inserted into an implanted port, were shown to core the silicone port's septum. Coring of port's septum may lead to: decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material; may lead to local tissue |
| Dec 23, 2009 | Z-0639-2010 | — | terminated | Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port |
| Dec 23, 2009 | Z-0640-2010 | — | terminated | Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port |