510(k) K980768 ยท FMI Needle, Hypodermic, Single Lumen
VACUETTE HOLDEX
| Applicant | Greiner Meditech, Inc., Bel Air MD, US |
| Decision | Substantially Equivalent, Apr 9, 1998 |
| Received | Feb 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2011 | Greiner Bio-One North America, Inc. HOLDEX Single-Use Holder PP closed pack.
Greiner Bio-One Austria Gmbh.
A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless stee Terminated |
FMI | None listed |
| Sep 30, 2008 | Greiner Bio-One North America, Inc. Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports. Terminated |
FMI | None listed |
| Sep 11, 2008 | Greiner Bio-One North America, Inc. Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.