Data / Medical devices / Canada / Medxl Inc
Medxl Inc: FDA-registered device maker in Pointe-Claire Quebec, Canada, 4 510(k) clearances
Medxl Inc is registered with the FDA (registration 3005934752) in Pointe-Claire Quebec, Canada. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005934752
- Address
- 285 Av. Labrosse, Pointe-Claire Quebec, Canada, H9R 1A3
- Owner or operator
- MedXL Inc (10056816)
- Roles
- Contract manufacturer, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- January 19, 2018
- Registered through
- 2026
- Brand names listed
- AMSafe SP 0.9% NaCl, AMSino scientific Inc., PraxiFill, PraxiLabel, Praxiject 0.9% NaCl, Praxiject SP 0.9% NaCl, Saline, Vascular access flush
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Contract manufacturer | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Foreign private label distributor | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract manufacturer | accessdata.fda.gov |
| System/Device, Pharmacy Compounding | NEP | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 27, 2024 | K233623 | Praxiject SP 0.9% NaCl | NGT | Substantially Equivalent | Medxl, Inc. | accessdata.fda.gov |
| July 13, 2023 | K231754 | Praxiject 0.9% NaCl | NGT | Substantially Equivalent | Medxl, Inc. | accessdata.fda.gov |
| February 13, 2020 | K192414 | Praxiject 0.9% NaCl | NGT | Substantially Equivalent | Medxl, Inc. | accessdata.fda.gov |
| December 21, 2017 | K171109 | Praxiject 0.9% NaCl | NGT | Substantially Equivalent | Medxl, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Saline, Vascular Access Flush
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Enteral Syringes With Enteral Specific Connectors
- All makers of System/Device, Pharmacy Compounding
Updated February 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.