Euro-Med Intl.: FDA clearances and approvals
Euro-Med Intl. has 16 FDA 510(k) clearances (first 1985, latest 1988), across 8 product codes in 3 review panels. Median 510(k) review time: 115 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | 7 | 7 |
| FZS | Curette, Surgical, General Use | 2 | 2 |
| EMF | Knife, Surgical | 1 | 1 |
| FTY | Tape, Measuring, Rulers And Calipers | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
| PCF | Sampler, Endocervical | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Euro-Med Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883884 | PROSTATIC CORE-CUT NEEDLE | KNW | 1988-12-05 | 83 |
| K882404 | KEVOR-CURETTE | PCF | 1988-07-08 | 28 |
| K854901 | PACIFIC GRASPER | KDC | 1986-05-02 | 147 |
| K854898 | ATLANTIC GRASPER | KDC | 1986-05-02 | 147 |
| K854897 | MAX-I-GRASP | KDC | 1986-05-02 | 147 |
| K854896 | HOOK SCISSOR | KDC | 1986-05-02 | 147 |
| K854895 | BASKET FORCEP | KDC | 1986-05-02 | 147 |
| K854894 | SPOON | KDC | 1986-05-02 | 147 |
| K854891 | KNIFE | EMF | 1986-05-02 | 147 |
| K854890 | HOOK PROBE | KDC | 1986-05-02 | 147 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Euro-Med Intl..
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 Euro-Med Intl. have?
Euro-Med Intl. has 16 FDA 510(k) clearances (first 1985, latest 1988), across 8 product codes in 3 review panels.
How long does FDA take to clear Euro-Med Intl.'s 510(k)s?
The median time from FDA receipt to decision across Euro-Med Intl.'s cleared 510(k)s is 115 days.
What devices does Euro-Med Intl. make?
Its most frequent FDA product codes are KDC (Instrument, Surgical, Disposable, 7); FZS (Curette, Surgical, General Use, 2); EMF (Knife, Surgical, 1).
Has Euro-Med Intl. had device recalls?
openFDA lists no recalls under a recalling firm name matching Euro-Med Intl. Related entities may recall under other names.
Next steps
- See all 16 Euro-Med Intl. clearances with predicates and recalls
- Run predicate analysis for product code KDC, Euro-Med Intl.'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.