Company ยท US
Greiner Vacuette North America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2002. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 1, 2002 | K014104 | VACUETTE EDTA K2 TUBES Greiner Vacuette North America, Inc. | PJE |
| Sep 24, 2001 | K012043 | VACUETTE EDTA K2 GEL TUBES Greiner Vacuette North America, Inc. | PJE |
| Jul 12, 2001 | K011786 | VACUETTE SAFETY BLOOD COLLECTION SET Greiner Vacuette North America, Inc. | FMI |
| Apr 30, 2001 | K003812 | VACUETTE SPEEDY QUICK-RELEASE HOLDER Greiner Vacuette North America, Inc. | FMI |
| Oct 5, 2000 | K002777 | VACUETTE WITH PPACK Greiner Vacuette North America, Inc. | JKA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2005 | Greiner VACUETTE North America Serum Blood Collection Tubes Terminated |
JKA | K960858 |
| Aug 10, 2004 | Greiner VACUETTE North America Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile Terminated |
GIM | K971221 |
| Jan 29, 2004 | Greiner VACUETTE North America Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria. Terminated |
FPA | K992145 |
| May 9, 2003 | Greiner VACUETTE North America Vacuette, Safety Blood Collection Set with Luer Adapter Terminated |
JKA | K011786 |