Biomedix Wai
Chanhassen, MN, US
BIOMEDIX WAI appears in FDA device records in Chanhassen, MN. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Biomedix Wai carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Biomedix, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 11 510(k) clearances for Biomedix Wai between 1993 and 2014. The busiest year on record is 1993, with 2. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1996 | 1 |
| 1997 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2007 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142097 | SELEC-3 I.V.ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K122281 | PADNET 2.0 | JOM | Substantially Equivalent | |
| K073146 | PADNET+ | JOM | Substantially Equivalent | |
| K050182 | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K042616 | BIOMEDIX PADNET LAB | JOM | Substantially Equivalent | |
| K033627 | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | JAF | Substantially Equivalent | |
| K973644 | FLOSTAT VASCULAR LAB | JAF | Substantially Equivalent | |
| K961928 | BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 | FPA | Substantially Equivalent | |
| K925645 | SELEC-3 | FPA | Substantially Equivalent | |
| K926498 | ENDOGRIP | BTR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1833470 | 1000115518 | BIOMEDIX WAI | 8600 Shelby Court, Chanhassen, MN 55317 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0023-2015 | 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 | Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain