Medicon EG: FDA clearances and approvals
Medicon EG has 17 FDA 510(k) clearances (first 1995, latest 2017), across 10 product codes in 4 review panels. Median 510(k) review time: 113 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 280 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Medicon EG's cleared 510(k)s took a median 280 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JEY | Plate, Bone | 7 | 7 |
| DZE | Implant, Endosseous, Root-Form | 2 | 2 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| HBB | Motor, Drill, Pneumatic | 1 | 1 |
| HBC | Motor, Drill, Electric | 1 | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 1 |
| HCH | Clip, Aneurysm | 1 | 1 |
| HCI | Applier, Aneurysm Clip | 1 | 1 |
| HFX | Clamp, Circumcision | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
Review panels
- Dental (9)
- Neurology (6)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
Most recent Medicon EG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161680 | MEDICON Spinal Spreading Systems | GZT | 2017-03-24 | 280 |
| K100916 | MEDICON MOGEN CLAMP | HFX | 2010-12-06 | 248 |
| K083803 | FIXIT HEADREST CLAMP SYSTEM | HBL | 2010-03-10 | 443 |
| K053624 | MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM | HRS | 2006-07-17 | 201 |
| K050478 | MEDICON IMF-ORION SCREWS | DZE | 2005-06-15 | 111 |
| K043297 | MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM | JEY | 2005-02-23 | 86 |
| K042974 | MEDICON VIPAIR HIGH SPEED SYSTEM | HBB | 2005-01-13 | 77 |
| K041527 | AARHUS ANCHORAGE SYSTEM | DZE | 2004-08-19 | 72 |
| K010910 | MEDICON YASARGIL CLIP APPLYING FORCEPS | HCI | 2001-08-01 | 128 |
| K010908 | MEDICON TITANIUM YASARGIL ANEURYSM CLIPS | HCH | 2001-08-01 | 128 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medicon EG.
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 Medicon EG have?
Medicon EG has 17 FDA 510(k) clearances (first 1995, latest 2017), across 10 product codes in 4 review panels.
How long does FDA take to clear Medicon EG's 510(k)s?
The median time from FDA receipt to decision across Medicon EG's cleared 510(k)s is 113 days.
What devices does Medicon EG make?
Its most frequent FDA product codes are JEY (Plate, Bone, 7); DZE (Implant, Endosseous, Root-Form, 2); GZT (Retractor, Self-Retaining, For Neurosurgery, 1).
Has Medicon EG had device recalls?
openFDA lists no recalls under a recalling firm name matching Medicon EG. Related entities may recall under other names.
Next steps
- See all 17 Medicon EG clearances with predicates and recalls
- Run predicate analysis for product code JEY, Medicon EG'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.