A single-blade bevelled surgical instrument intended for use in cutting or contouring the bones of the middle ear, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or
| Company | Devices | Share |
|---|---|---|
| Bausch & Lomb Incorporated | 62 | 51% |
| Boss Instruments, Ltd., Inc. | 9 | 7% |
| Gyrus Acmi, Llc | 9 | 7% |
| Ambler Surgical Corp. | 7 | 6% |
| Integra Lifesciences Production Corporation | 6 | 5% |
| Surgix Medical Llc | 5 | 4% |
| Steris Corporation | 5 | 4% |
| Sklar Corporation | 5 | 4% |
| Avalign Technologies, Inc. | 4 | 3% |
| Spiggle & Theis Medizintechnik Gmbh | 3 | 2% |
| Teleflex Incorporated | 2 | 2% |
| Integra Microfrance | 2 | 2% |
Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| JYE | CHISEL, MIDDLE-EAR | 29 |
| GFI | Osteotome, Manual | 25 |
| FTY | Tape, Measuring, Rulers And Calipers | 14 |
| LRC | INSTRUMENT, ENT MANUAL SURGICAL | 12 |
| KBA | Rasp, Nasal | 11 |
| JYE | Chisel, Middle-Ear | 10 |
Use these as the dimensions to specify in a tender line.
122 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Middle ear chisel", from 14 companies. The largest labeler is Bausch & Lomb Incorporated with 51% of records.
JYE (CHISEL, MIDDLE-EAR), GFI (Osteotome, Manual), FTY (Tape, Measuring, Rulers And Calipers), LRC (INSTRUMENT, ENT MANUAL SURGICAL)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.