Bowen & Company, Inc.
Medical device manufacturer in Rockville, MD.
14510(k) clearances
0PMA approvals
0recalls
Device types
- HXI Passer, Wire, Orthopedic 2
- GAC Rasp, Surgical, General & Plastic Surgery 1
- HWE Instrument, Surgical, Orthopedic… 1
- HTW Bit, Drill 1
- HXB Probe 1
- GEA Cannula, Surgical, General & Plastic Surgery 1
- HTD Forceps 1
- HTZ Instrument, Cutting, Orthopedic 1
- DRX Electrode, Electrocardiograph 1
- EIL Gauge, Depth, Instrument, Dental 1
- KIJ Instrument, Surgical, Orthopedic… 1
- HRX Arthroscope 1
- LKB Pad, Alcohol, Device Disinfectant 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K896898 | Bowen Electrode Skin Prepatory CleanserLKB · Traditional | 04/04/1990SE |
| K896538 | Disposable 45 Degree ShaverHRX · Traditional | 12/06/1989SE |
| K873766 | Sternal Power AwlKIJ · Traditional | 11/14/1988SE |
| K872098 | Cremeen Alveolar Bone CaliperEIL · Traditional | 07/31/1987SE |
| K871325 | Bowen Reuseable/Disposable ElectrodeDRX · Traditional | 06/08/1987SE |
| K870882 | 45 Degree ShaverHTZ · Traditional | 03/23/1987SE |
| K870881 | Loose Body GraspersHTD · Traditional | 03/23/1987SE |
| K863150 | Bowen CannulaGEA · Traditional | 09/05/1986SE |
| K863149 | Bowen ProbeHXB · Traditional | 09/05/1986SE |
| K863148 | Bowen Knot PasserHXI · Traditional | 09/05/1986SE |
| K863147 | Glenoid DrillHTW · Traditional | 09/05/1986SE |
| K863146 | Bowen Suture PasserHXI · Traditional | 09/05/1986SE |
| K853376 | Morgan Suture-DrillHWE · Traditional | 11/13/1985SE |
| K853601 | Morgan Arthroscopic Menesus & Synovial RaspGAC · Traditional | 09/16/1985SE |