Xomed, Inc.: FDA clearances and approvals
Xomed, Inc. has 82 FDA 510(k) clearances (first 1976, latest 2000), across 44 product codes in 11 review panels. Median 510(k) review time: 46 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETD | Tube, Tympanostomy | 13 | 13 |
| LXB | Hearing Aid, Bone Conduction | 6 | 6 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 5 | 5 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 5 | 5 |
| ETB | Prosthesis, Partial Ossicular Replacement | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| KAM | Cannula, Sinus | 3 | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 2 |
| EPP | Splint, Nasal | 2 | 2 |
| ETN | Stimulator, Nerve | 2 | 2 |
Plus 34 more product codes.
Review panels
- Ear, Nose and Throat (51)
- General and Plastic Surgery (15)
- General Hospital (3)
- Orthopedic (3)
- Ophthalmic (2)
- Anesthesiology (1)
- Cardiovascular (1)
- Dental (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
- Physical Medicine (1)
Most recent Xomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | HKX | 2000-12-11 | 126 |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | GEI | 2000-12-04 | 70 |
| K002828 | XPS NITRO SYSTEM | ERL | 2000-10-17 | 36 |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | ETB | 2000-10-11 | 23 |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | HET | 2000-06-09 | 224 |
| K001148 | MEROGEL OTOLOGIC PACK | KHJ | 2000-06-03 | 54 |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | KAM | 2000-02-08 | 53 |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | QPB | 2000-01-21 | 150 |
| K993582 | MODIFICATION TO LASER-SHIELD II | BTR | 2000-01-20 | 90 |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | GEI | 1999-12-21 | 53 |
72 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Xomed, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Xomed, Inc. have?
Xomed, Inc. has 82 FDA 510(k) clearances (first 1976, latest 2000), across 44 product codes in 11 review panels.
How long does FDA take to clear Xomed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Xomed, Inc.'s cleared 510(k)s is 46 days.
What devices does Xomed, Inc. make?
Its most frequent FDA product codes are ETD (Tube, Tympanostomy, 13); LXB (Hearing Aid, Bone Conduction, 6); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 5).
Has Xomed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Xomed, Inc. Related entities may recall under other names.
Next steps
- See all 82 Xomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETD, Xomed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.