Ultimed, Inc.
St. Paul, MN, US
Ultimed, Inc. appears in FDA device records in St. Paul, MN. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Ultimed, Inc. between 2000 and 2010. The busiest year on record is 2008, with 2. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100812 | ULTICARE DISPOSABLE PEN NEEDLES | FMI | Substantially Equivalent | |
| K080600 | ULTIMED ULTICARE SAFETY SYRINGE | MEG | Substantially Equivalent | |
| K081449 | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER | MMK | Substantially Equivalent | |
| K062702 | ULTICARE DISPOSABLE SYRINGES AND NEEDLES | FMF | Substantially Equivalent | |
| K050464 | ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 | FMI | Substantially Equivalent | |
| K033794 | ULTICARE DISPOSABLE SYRINGE 3 ML/CC | FMF | Substantially Equivalent | |
| K021983 | ULTI GUARD HOME INSULIN SYRINGE CONTAINER | MMK | Substantially Equivalent | |
| K994230 | ULTICARE DISPOSABLE SYRINGE | FMF | 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