Dumex Medical Surgical Products, Ltd.
Toronto, Orntario, CA
Dumex Medical Surgical Products, Ltd. appears in FDA device records in Toronto, Orntario, CA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Dumex Medical Surgical Products, Ltd. between 1994 and 2000. The busiest year on record is 1998, with 5. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 1 |
| 1998 | 5 |
| 1999 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992732 | STERILE WATER & STERILE 0.9% SODIUM CHLORIDE | FOZ | Substantially Equivalent | |
| K993119 | STERILE HYDROGEL | MGQ | Substantially Equivalent | |
| K990332 | DUMEX IODOFORM PACKING STRIP | FRO | Substantially Equivalent for Some Indications | |
| K980779 | THALAFIX NATURAL SEA SALT DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K980861 | DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL | MGQ | Substantially Equivalent | |
| K980863 | DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) | KMF | Substantially Equivalent | |
| K980777 | DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING | FRO | Substantially Equivalent | |
| K980791 | DUMEX PAK-ITS WOVEN RIBBON PACKING | EFQ | Substantially Equivalent | |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | NAD | Substantially Equivalent | |
| K950132 | DUMEX WET DRESSINGS | FRO | Substantially Equivalent for Some Indications | |
| K946326 | DUTEX GAUZE BANDAGE | EFQ | Substantially Equivalent | |
| K945830 | DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE) | EFQ | Substantially Equivalent | |
| K941217 | DUPAQUE SPONGE | GDY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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