Bowen & Company, Inc.
Rockville, MD, US
Bowen & Company, Inc. appears in FDA device records in Rockville, MD. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Bowen & Company, Inc. between 1985 and 1990. The busiest year on record is 1986, with 5. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 5 |
| 1987 | 4 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K896898 | BOWEN ELECTRODE SKIN PREPATORY CLEANSER | LKB | Substantially Equivalent | |
| K896538 | DISPOSABLE 45 DEGREE SHAVER | HRX | Substantially Equivalent | |
| K873766 | STERNAL POWER AWL | KIJ | Substantially Equivalent | |
| K872098 | CREMEEN ALVEOLAR BONE CALIPER | EIL | Substantially Equivalent | |
| K871325 | BOWEN REUSEABLE/DISPOSABLE ELECTRODE | DRX | Substantially Equivalent | |
| K870882 | 45 DEGREE SHAVER | HTZ | Substantially Equivalent | |
| K870881 | LOOSE BODY GRASPERS | HTD | Substantially Equivalent | |
| K863150 | BOWEN CANNULA | GEA | Substantially Equivalent | |
| K863149 | BOWEN PROBE | HXB | Substantially Equivalent | |
| K863148 | BOWEN KNOT PASSER | HXI | Substantially Equivalent | |
| K863147 | GLENOID DRILL | HTW | Substantially Equivalent | |
| K863146 | BOWEN SUTURE PASSER | HXI | Substantially Equivalent | |
| K853376 | MORGAN SUTURE-DRILL | HWE | Substantially Equivalent | |
| K853601 | MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP | GAC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HRXArthroscope
- HTWBit, Drill
- GEACannula, Surgical, General & Plastic Surgery
- DRXElectrode, Electrocardiograph
- HTDForceps
- EILGauge, Depth, Instrument, Dental
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- LKBPad, Alcohol, Device Disinfectant
- HXIPasser, Wire, Orthopedic
- HXBProbe
- GACRasp, Surgical, General & Plastic Surgery
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain