Panels › Hematology › Product code KSR · Class 2
Container, Empty, For Collection & Processing Of Blood & Blood Components
Regulation 864.9100
0510(k)s in 12 months (16 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in KSR
| Company | 510(k)s | Recalls |
|---|---|---|
| Haemonetics Corp. | 3 | 0 |
| Becton Dickinson & Company | 0 | 2 |
| Delmed, Inc. | 2 | 0 |
| DeRoyal Industries Inc | 0 | 2 |
| Travenol Laboratories, S.A. | 2 | 0 |
| Alpha Therapeutic Corp. | 1 | 0 |
| Cry-O-Safe, Inc. | 1 | 0 |
| Deroyal | 1 | 0 |
| Dravon Medical, Inc. | 1 | 0 |
| Gambro, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2012 | DeRoyal Industries Inc DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849
Product Usage: Collection of cord blood Terminated |
KSR | K020753 |
| Apr 12, 2012 | DeRoyal Industries Inc DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849
Product Usage: Collection of cord blood Terminated |
KSR | K020753 |
| Sep 9, 2006 | Becton Dickinson & Company BD Direct Draw Adapters, Catalog Number 364896. Terminated |
KSR | None listed |
| Jan 11, 2006 | Becton Dickinson & Company BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder. Terminated |
KSR | K011984 |
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