Company
Bard Medical Division
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2019 | Bard Medical Division SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A3034 Terminated |
MJC | K910318 |
| Dec 6, 2018 | Bard Medical Division BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile.
Intended for use Open, Classified |
MJC | K910318 |
| Jun 13, 2018 | Bard Medical Division Arctic Sun Temperature Management System, Model 5000.
The Arctic Sun 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a ra Terminated |
DWJ | K161602 |
| Mar 21, 2018 | Bard Medical Division Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drain Terminated |
FMH | None listed |
| Nov 8, 2017 | Bard Medical Division Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads:
Description, Catalog Number
a) Intrepid ArcticGel Small Pad Kit, 31705I
b) Intrepid ArcticGel Medium Pad Kit, 31707I
c) Intrepid ArcticGel Large Pad Kit, Terminated |
DWJ | K142702 |