Ortho Pharmaceutical Corp.
Walker, MI, US
Ortho Pharmaceutical Corp. 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 Ortho Pharmaceutical Corp. between 1979 and 1996. The busiest year on record is 1980, with 2. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 2 |
| 1981 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1991 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K955648 | K-Y PERSONAL LUBRICANT | HIS | Substantially Equivalent | |
| K934516 | ADVANCE PREGNANCY TEST MODIFICATION | LCX | Substantially Equivalent | |
| K914990 | ADVANCE(R) PREGNANCY TEST | LCX | Substantially Equivalent | |
| K893488 | PULSATILE PUMP FOR GONADORELIN ACETATE | FRN | Substantially Equivalent | |
| K881151 | MICROSCRAPE | LXK | Substantially Equivalent | |
| K810581 | FACT* HOME PREGNANCY TEST | JHJ | Substantially Equivalent | |
| K800754 | NICKERSON'S MED. SELECTIVE CULTURE MEDIU | JSJ | Substantially Equivalent | |
| K792634 | CONCEPTROL/THIN PROPHYLACTICS | HIS | Substantially Equivalent | |
| K790087 | LUBRICANT, OTRHO PERSONAL | KMJ | 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