Amedic USA: FDA clearances and approvals
Amedic USA has 10 FDA 510(k) clearances (first 1987, latest 1990), across 8 product codes in 5 review panels. Median 510(k) review time: 128 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 |
|---|---|---|---|
| FCG | Biopsy Needle | 2 | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | 2 | 2 |
| FFF | Cover, Biopsy Forceps | 1 | 1 |
| FZX | Guide, Surgical, Instrument | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| JOT | Electrode, Gel, Electrosurgical | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
Review panels
- Gastroenterology and Urology (3)
- General and Plastic Surgery (3)
- Obstetrics and Gynecology (2)
- General Hospital (1)
- Radiology (1)
Most recent Amedic USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K897120 | EQUIP COVERS, STERILE | KKX | 1990-01-04 | 9 |
| K892070 | GENERAL IVT NEEDLE GUIDE KIT, STERILE | HGL | 1989-09-05 | 158 |
| K892071 | GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE | KNW | 1989-08-08 | 130 |
| K892069 | EXTENDED COVERS, STERILE | FFF | 1989-08-08 | 130 |
| K892068 | TRT (ACUSON) NEEDLE GUIDE KIT, STERILE | FCG | 1989-08-04 | 127 |
| K871467 | BIOPSY NEEDLE GUIDE KIT, STERILE | FCG | 1987-08-21 | 129 |
| K871609 | ULTRASOUND TRANSDUCER SHEATHS, STERILE | ITX | 1987-07-15 | 82 |
| K871565 | ULTRASOUND TRANSDUCER GEL, STERILE | JOT | 1987-07-15 | 84 |
| K871503 | BIOPSY NEEDLE GUIDE KIT, STERILE | FZX | 1987-07-10 | 84 |
| K864219 | TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE | HGL | 1987-03-27 | 150 |
Recalls
openFDA lists no recalls under a recalling firm named Amedic USA.
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 Amedic USA have?
Amedic USA has 10 FDA 510(k) clearances (first 1987, latest 1990), across 8 product codes in 5 review panels.
How long does FDA take to clear Amedic USA's 510(k)s?
The median time from FDA receipt to decision across Amedic USA's cleared 510(k)s is 128 days.
What devices does Amedic USA make?
Its most frequent FDA product codes are FCG (Biopsy Needle, 2); HGL (Transducer, Ultrasonic, Obstetric, 2); FFF (Cover, Biopsy Forceps, 1).
Has Amedic USA had device recalls?
openFDA lists no recalls under a recalling firm name matching Amedic USA. Related entities may recall under other names.
Next steps
- See all 10 Amedic USA clearances with predicates and recalls
- Run predicate analysis for product code FCG, Amedic USA'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.