FEI 3004949275Initial importer
Brasseler U.s.a. Medical, Llc
1 Brasseler Blvd, Savannah, GA, US
MDR events36All time
Recalls0All time
Registered products15
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
15 product codes
Recent MDR events
36 on file
- KM166-00-00 TWIST DRILL STANDARD ROUND SHANK LENGTH 5 IN DIAMETER 1/16 INJun 17, 2024Injury2025102-2024-00007
- KM166-00-01 TWIST DRILL STANDARD ROUND SHANK LENGTH 5 IN DIAMETER 5/64 INJun 17, 2024Injury2024102-2024-00008
- KM-250R 60.0 X 6.33MM RECIP 0.64MM MAT THK / 1.04MM CUT THKJun 11, 2024Malfunction2025102-2024-00006
- STANDARD BURR, SERRATED LINDEMANN FLUTEDJun 10, 2024MalfunctionMW5156106
- BRASSELERMay 3, 2024Malfunction19237926
- BUR, SURGICAL, GENERAL AND PLASTIC SURGERYAug 12, 2023MalfunctionMW5142539
- BRASSELER LARGE BONE BLADEMar 24, 2023MalfunctionMW5115967
- DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)Oct 12, 2022Malfunction15592634
- 2.0 MM TWIST DRILL BITJan 15, 2021MalfunctionMW5098855
- BRASSELER USA K-WIRES SMOOTHOct 30, 2020Injury2025102-2020-00001
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3004949275.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.