Artiberia: FDA clearances and approvals
Artiberia has 79 FDA 510(k) clearances (first 1985, latest 1985), across 45 product codes in 8 review panels. Median 510(k) review time: 56 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 |
|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | 6 | 6 |
| EMG | Forceps, Tooth Extractor, Surgical | 4 | 4 |
| KAE | Forceps, Ent | 3 | 3 |
| EMJ | Elevator, Surgical, Dental | 2 | 2 |
| ERA | Otoscope | 2 | 2 |
| FHQ | Holder, Needle, Gastroenterologic | 2 | 2 |
| GDL | Needle, Suturing, Reusable | 2 | 2 |
| HNR | Forceps, Ophthalmic | 2 | 2 |
| HTD | Forceps | 2 | 2 |
| LRW | Scissors, General, Surgical | 2 | 2 |
Plus 35 more product codes.
Review panels
- General and Plastic Surgery (22)
- Dental (20)
- Ear, Nose and Throat (6)
- Gastroenterology and Urology (4)
- Ophthalmic (4)
- Neurology (2)
- Orthopedic (2)
- Obstetrics and Gynecology (1)
Most recent Artiberia 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851745 | 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B | ERA | 1985-08-29 | 126 |
| K851786 | 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF | LGG | 1985-07-09 | 75 |
| K851730 | 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST | EJY | 1985-07-02 | 68 |
| K851729 | 2620/1 TO 2635/2 VARIOUS DENTAL CROWN SCISSORS | EIR | 1985-07-02 | 68 |
| K851727 | 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA | EIK | 1985-07-02 | 68 |
| K851726 | 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN | EIY | 1985-07-02 | 68 |
| K851724 | 1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS | EKB | 1985-07-02 | 68 |
| K851723 | 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS | EKD | 1985-07-02 | 68 |
| K851722 | 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS | EKC | 1985-07-02 | 68 |
| K851721 | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | EMN | 1985-07-02 | 68 |
69 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Artiberia.
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 Artiberia have?
Artiberia has 79 FDA 510(k) clearances (first 1985, latest 1985), across 45 product codes in 8 review panels.
How long does FDA take to clear Artiberia's 510(k)s?
The median time from FDA receipt to decision across Artiberia's cleared 510(k)s is 56 days.
What devices does Artiberia make?
Its most frequent FDA product codes are GEN (Forceps, General & Plastic Surgery, 6); EMG (Forceps, Tooth Extractor, Surgical, 4); KAE (Forceps, Ent, 3).
Has Artiberia had device recalls?
openFDA lists no recalls under a recalling firm name matching Artiberia. Related entities may recall under other names.
Next steps
- See all 79 Artiberia clearances with predicates and recalls
- Run predicate analysis for product code GEN, Artiberia'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.