510(k) K922522 ยท FMF Syringe, Piston
MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES
| Applicant | Sherwood Medical Co., St. Louis MO, US |
| Decision | Substantially Equivalent, Nov 25, 1992 |
| Received | May 28, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2012 | Covidien LLC Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2"
Product ID: 8881511144
Indications for Use: Injection of U-1 00 insulin Terminated |
FMF | None listed |
| May 31, 2012 | Covidien LLC Monoject Insulin Safety Syringe 3/10mL 30 X 5/16"
Product ID: 8881511344
Indications for Use: Injection of U-1 00 insulin Terminated |
FMF | None listed |
| May 31, 2012 | Covidien LLC Monoject Insulin Safety Syringe 1/2mL 29 X 1/2"
Product ID: 8881511136
Indications for Use: Injection of U-1 00 insulin Terminated |
FMF | None listed |
| May 31, 2012 | Covidien LLC Monoject Insulin Safety Syringe 1/2mL 30 X 5/16"
Product ID: 8881511336
Indications for Use: Injection of U-1 00 insulin Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.