Company ยท US
Brasseler USA I, L.P.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2003. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 3, 2003 | K030172 | SMALL HIGH SPEED MOTOR DRILL SYSTEM Brasseler USA I, L.P. | HBE |
| Jan 14, 1999 | K983223 | DENTAL STERLIZATION TRAY/CASSETTE Brasseler USA I, L.P. | FRG |
| Jan 5, 1996 | K955140 | 2.0 X 6MM SCREW Brasseler USA I, L.P. | DZL |
| Mar 7, 1995 | K945670 | KIRSCHNER (K-WIRE), STEINMAN PINS Brasseler USA I, L.P. | JDW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2024 | Brasseler USA I Lp Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx. Open, Classified |
EJL | None listed |
| Dec 11, 2019 | Brasseler USA I Lp Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm
Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures. Terminated |
HTY | K945670 |
| Oct 18, 2019 | Brasseler USA I Lp BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries. Terminated |
GFF | K872475 |