Data / Medical devices / Canada / Medionics International, Inc.
Medionics International, Inc.: FDA-registered device maker in MARKHAM Ontario, Canada, 2 510(k) clearances
Medionics International, Inc. is registered with the FDA (registration 9611088) in MARKHAM Ontario, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 19, 2013. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611088
- FEI number
- 3002807599
- Address
- 114 Anderson Ave., MARKHAM Ontario, Canada, L6E 1A5
- Owner or operator
- MEDIONICS INTERNATIONAL, INC. (8020321)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2027
- Brand names listed
- Faller Stylet #FS-401, Faller Stylet #FS-402, Faller Stylet #FS-403, Faller Stylet #FS-404, Peritoneal Dialysis Catheter #CA-1157, Peritoneal Dialysis Catheter #CA-1162, Peritoneal Dialysis Catheter #CA-2262, Peritoneal Dialysis Catheter #CA-2272 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Peritoneal | GBW | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Peritoneal, Long-Term Indwelling | FJS | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 19, 2013 | K130441 | FALLER STYLET | FJS | Substantially Equivalent | Medionics International, Inc. | accessdata.fda.gov |
| April 28, 2000 | K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | FJS | Substantially Equivalent | Medionics International, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 19, 2013. 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.