Omega-Med Intl., Inc.
Walker, MI, US
Omega-Med Intl., Inc. appears in FDA device records in Walker, MI. FDA records list 9 510(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
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Omega-Med Intl., Inc. between 1981 and 1984. The busiest year on record is 1981, with 4. The most recent is 1984, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 4 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K842603 | OMED DISPOS. INSTRUMENT GUARDS | Substantially Equivalent | ||
| K832441 | SUTURE-AID BOOTIES | KDC | Substantially Equivalent | |
| K830484 | OMED IDENT-I-BAND | Substantially Equivalent | ||
| K822284 | COMPLY NEUROMUSCULAR STIMULATOR | IPF | Substantially Equivalent | |
| K821334 | OMED FABRIC INSTRUMENT COVERS-RADIOPAQ | Substantially Equivalent | ||
| K813499 | OMED DISPOSABLE BULLDOG | DXC | Substantially Equivalent | |
| K810883 | OMED SILICONE INSTRUMENT COVERS | KDC | Substantially Equivalent | |
| K810269 | OMED FABRIC INSTRUMENT COVERS | KDC | Substantially Equivalent | |
| K810260 | OMED SILICONE LOOPS | KDC | 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