Medionics International, Inc.
MARKHAM Ontario, CA
MEDIONICS INTERNATIONAL, INC. appears in FDA device records in MARKHAM Ontario, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Medionics International, Inc. between 1982 and 2013. The busiest year on record is 1983, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1988 | 1 |
| 1992 | 1 |
| 1995 | 1 |
| 2000 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130441 | FALLER STYLET | FJS | Substantially Equivalent | |
| K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | FJS | Substantially Equivalent | |
| K994218 | EASY CARE AND TUBING SETS | FKX | Substantially Equivalent | |
| K945567 | QC CAP | KDJ | Substantially Equivalent | |
| K910173 | SELECTRA AND TUBING SETS | FKX | Substantially Equivalent | |
| K883393 | CAPD DISPOSABLE Y SYSTEM - DY SET | KDJ | Substantially Equivalent | |
| K842305 | C.A.P.D. AUTOMATIC HEATER PDH 200 | FKX | Substantially Equivalent | |
| K832141 | MICROSTAR VC1 VOLUMETRIC CYCLER | FKX | Substantially Equivalent | |
| K831766 | MICROSTAR VCI | FKX | Substantially Equivalent | |
| K821328 | C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP | KPF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611088 | 3002807599 | MEDIONICS INTERNATIONAL, INC. | 114 ANDERSON AVE., MARKHAM Ontario L6E 1A5 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain