Bolder Surgical, LLC
Bolder Surgical, LLC holds FDA 510(k) medical device clearances, first cleared 2020, most recent 2023, with 1 FDA device recall on record.
Top product codes for Bolder Surgical, LLC
FDA recalls by Bolder Surgical, LLC
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Bolder Surgical, LLC
- K231012 — CoolSeal Trinity
- K211579 — CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
- K203183 — CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
- K203640 — CoolSeal Reveal
- K202114 — CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20
Data sourced from openFDA. This site is unofficial and independent of the FDA.