510(k) K041399 ยท FMI Needle, Hypodermic, Single Lumen
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
| Applicant | Smiths Medical Asd, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Jul 28, 2004 |
| Received | May 26, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K041399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2019 | Smiths Medical ASD Inc. Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile
Product Usage:
Is a disposable, single use device intended for injection or aspiration of fluids using a Lue Terminated |
FMI | None listed |
| Dec 30, 2014 | Smiths Medical ASD, Inc. Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010
Product Usage:
The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer Completed |
FMI | None listed |
| Dec 30, 2014 | Smiths Medical ASD, Inc. Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010
Product Usage:
The Needle Pro Edge Safety Hypodermic Needle is intended for injection or Completed |
FMI | None listed |
| Dec 30, 2014 | Smiths Medical ASD, Inc. Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010
Product Usage:
The Needle Pro Edge Safety Hypodermic Needle is intended for injection or as Completed |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.