Panels › Anesthesiology › Product code OFU · Class 2
Spinal Anesthesia Kit
Regulation 868.5120
0510(k)s in 12 months (0 all time)
3recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in OFU
| Company | 510(k)s | Recalls |
|---|---|---|
| B Braun Medical Inc | 0 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2026 | B Braun Medical Inc Design Options Spinal Tray
Spinal Needle Anesthesia procedure kits:
Material Description (Material Number):
SSK H M C 20061890 (560074),
SSK S C H (560214),
SSK BJC H S (ORIGINAL CUST) (560272), Open, Classified |
OFU | None listed |
| Jun 3, 2026 | B Braun Medical Inc Spinocan Spinal Needle procedure kits:
Material Description (Material Number):
Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201);
Spinocan 25 Ga. x 3-1 Open, Classified |
OFU | None listed |
| Jun 3, 2026 | B Braun Medical Inc Spinal Needle procedure kits:
Material Description (Material Number)
24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867);
25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862);
GOVP24BK 24G PENCAN TRAY Open, Classified |
OFU | None listed |
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