Company ยท US
Biomedix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2014. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 29, 2014 | K142097 | SELEC-3 I.V.ADMINISTRATION SET Biomedix, Inc. | FPA |
| Aug 29, 2012 | K122281 | PADNET 2.0 Biomedix, Inc. | JOM |
| Nov 21, 2007 | K073146 | PADNET+ Biomedix, Inc. | JOM |
| Aug 9, 2005 | K050182 | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM Biomedix, Inc. | CGA |
| Oct 12, 2004 | K042616 | BIOMEDIX PADNET LAB Biomedix, Inc. | JOM |
| May 21, 2004 | K033627 | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM Biomedix, Inc. | CGA |
| Dec 29, 1997 | K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) Biomedix, Inc. | JAF |
| Dec 23, 1997 | K973644 | FLOSTAT VASCULAR LAB Biomedix, Inc. | JAF |
| Sep 16, 1996 | K961928 | BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 Biomedix, Inc. | FPA |
| Sep 27, 1993 | K925645 | SELEC-3 Biomedix, Inc. | FPA |
| Apr 7, 1993 | K926498 | ENDOGRIP Biomedix, Inc. | BTR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2014 | Biomedix, Inc. Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE Terminated |
FPA | K142097 |