Ormed Mfg., Inc.
Mchenry, IL, US
Ormed Mfg., Inc. appears in FDA device records in Mchenry, IL. FDA records list 23 510(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
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Ormed Mfg., Inc. between 1983 and 1994. The busiest year on record is 1988, with 12. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 7 |
| 1985 | 1 |
| 1987 | 2 |
| 1988 | 12 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K931555 | ARTROMOT K2 CPM | BXB | Substantially Equivalent | |
| K882530 | TAPE STRUNG TONSIL SPONGE | EFQ | Substantially Equivalent | |
| K882529 | BUTCHER STRUNG TONSIL SPONGE | EFQ | Substantially Equivalent | |
| K882528 | CYLINDRICAL SPONGE | EFQ | Substantially Equivalent | |
| K882527 | GAUZE SPONGE | EFQ | Substantially Equivalent | |
| K880911 | BLUNT SPONGE | EFQ | Substantially Equivalent | |
| K880910 | ROUND STICK SPONGES | EFQ | Substantially Equivalent | |
| K880909 | TRACHEOTOMY SPONGES | EFQ | Substantially Equivalent | |
| K880907 | TRIANGLE SPONGE | EFQ | Substantially Equivalent | |
| K880854 | STRUNG ABSORBENT BALLS | EFQ | Substantially Equivalent | |
| K880853 | CHERRY SPONGE | EFQ | Substantially Equivalent | |
| K880852 | ROSEBUD DISSECTORS | EFQ | Substantially Equivalent | |
| K880851 | FLAT STICK SPONGE | EFQ | Substantially Equivalent | |
| K873831 | EAR AND EYE SPONGES | EFQ | Substantially Equivalent | |
| K873391 | MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8 | GDY | Substantially Equivalent | |
| K852202 | STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE | EFQ | Substantially Equivalent | |
| K831936 | PRE-ROLLED TUBULAR STOCKINETTE | Substantially Equivalent | ||
| K831914 | STRUNG NEURO SPONGE PATTIES-X-RAY- | GDY | Substantially Equivalent | |
| K831912 | ROUND-BEEHIVE- DISSECTORS 3/8 | GDI | Substantially Equivalent | |
| K831913 | COLOR-EZE PRE-WASHED LAP SPONGES | GDY | Substantially Equivalent | |
| K832047 | STERILE SUTURE REMOVAL SET | KDD | Substantially Equivalent | |
| K831915 | SAFETY PINS & RUBBER BANDS | KDC | Substantially Equivalent | |
| K831911 | DISPOSABLE FLOOR INSTRUMENTS | 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