Medamicus, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Medamicus, Inc.” (first 1989, latest 2004), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 14 | 14 |
| FEN | Device, Cystometric, Hydraulic | 3 | 3 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 2 | 2 |
| DXO | Transducer, Pressure, Catheter Tip | 1 | 1 |
Review panels
- Cardiovascular (15)
- Gastroenterology and Urology (3)
- Neurology (2)
Most recent Medamicus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040150 | MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | DYB | 2004-02-18 | 26 |
| K030905 | MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | DYB | 2003-04-09 | 16 |
| K022689 | MODIFICATION TO MEDAMICUS AXIA RSN | DYB | 2002-08-23 | 10 |
| K021004 | VALVED PEELABLE INTRODUCER | DYB | 2002-06-06 | 70 |
| K020563 | MEDAMICUS AXIA RSN | DYB | 2002-05-21 | 90 |
| K013120 | PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 | GZB | 2002-01-24 | 128 |
| K011085 | GUIDEWIRE INTRODUCER SAFETY NEEDLE | DYB | 2001-07-09 | 90 |
| K000824 | PERCUTANEOUS INTRODUCER, MODEL 10383-XXX | DYB | 2000-04-13 | 30 |
| K994097 | MEDAMICUS EPIDURAL INTRODUCER | GZB | 2000-03-01 | 89 |
| K990705 | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET | DYB | 1999-06-28 | 116 |
10 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-06-06.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medamicus, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Medamicus, Inc.” (first 1989, latest 2004), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medamicus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medamicus, Inc. is 90 days.
Which FDA product codes appear under Medamicus, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 14); FEN (Device, Cystometric, Hydraulic, 3); GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief), 2).
Next steps
- See all 20 Medamicus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Medamicus, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.