EMH
8 FDA 510(k) clearances · Product code
47 daysmedian time to decision
123 days90th percentile
8clearances measured
FDA profile
- Official device name
- Forceps, Rongeur, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1995: 1 · 1998: 1 · 2001: 1 · 2003: 1 · 2006: 4 · 2007: 2
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 |
|---|---|---|
| BONE RONGEUR, DOUBLE-ACTION (K890256) | Kinetic Medical Products | 1989-01-27 |
| BONE RONGEUR, SINGLE-ACTION (K890255) | Kinetic Medical Products | 1989-01-27 |
| MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT (K854887) | Walter Lorenz Surgical, Inc. | 1986-02-28 |
| 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC (K851710) | Artiberia | 1985-06-11 |
| JAKOBI SURG. INSTRUMENTS #8 15 (K834190) | Imm Enterprises , Ltd. | 1984-03-06 |
| SURGICAL INSTRUMENTS & ACCESSORIES (K834366) | C.B.S. Biotechnics, Inc. | 1984-02-27 |
| MODIFIED RONGEURS FOR SPINAL & ORTH. S. (K821358) | Downs Surgical , Ltd. | 1982-05-28 |
| FORCEPS, STYLE #849 (K771522) | Premier Dental Products Co. | 1977-08-16 |
Track EMH automatically
Every clearance here is in the API, with alerts when new ones post.