KDG
11 FDA 510(k) clearances · Product code
28 daysmedian time to decision
72 days90th percentile
11clearances measured
FDA profile
- Official device name
- Chisel (Osteotome)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1997: 3 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (K952678) | Avail-Southwest Division | 1995-07-10 |
| OMNI-JUG (K952200) | Waterstone Medical, Inc. | 1995-06-29 |
| SURGICAL CHISEL/OSTEOTOME (K894785) | Fdt Precision Machine Co., Inc. | 1989-08-18 |
| SIL-MED WASTE FLUID DUMP BAG (K891471) | Sil-Med Corp. | 1989-08-15 |
| POREX QUALITY PLASTIC SURGERY INSTRUMENTS (K872947) | Porex Medical | 1987-08-21 |
| OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (K872092) | Military Engineering, Inc. | 1987-06-23 |
| CHERMEL BONE CHISELS (K842824) | Cher Mel Corp. | 1984-08-02 |
| ANDERSON-NEIVERT OSTEOTOME (K772373) | Edward Weck, Inc. | 1978-03-09 |
| NEIVERT OSTEOTOME (K772376) | Edward Weck, Inc. | 1978-03-09 |
| SILVER OSTEOTOME (K772374) | Edward Weck, Inc. | 1978-03-09 |
| CEMENT EXTRACTION INSTRUMENT SET (K780135) | Orthopedic Equipment Co., Inc. | 1978-01-31 |
Track KDG automatically
Every clearance here is in the API, with alerts when new ones post.