Flexmedics: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Flexmedics” (first 1986, latest 1999), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | 7 | 7 |
| DQX | Wire, Guide, Catheter | 4 | 4 |
| DZC | Wire, Orthodontic | 2 | 2 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 2 | 2 |
| EJW | Clasp, Wire | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| HXB | Probe | 1 | 1 |
| KNY | Accessories, Catheter, G-U | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (10)
- Cardiovascular (4)
- Gastroenterology and Urology (3)
- Orthopedic (2)
Most recent Flexmedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990765 | FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO | OCY | 1999-03-15 | 7 |
| K964955 | FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING | OCY | 1997-02-14 | 65 |
| K952430 | FINESSE GUIDEWIRE CORONARY | DQX | 1995-08-18 | 86 |
| K943390 | FLEXFINDER GUIDEWIRE | DQX | 1995-06-27 | 348 |
| K942074 | FLEXFINDER GUIDEWIRE | KNY | 1994-06-24 | 56 |
| K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | DZC | 1994-01-21 | 143 |
| K912843 | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | HXB | 1991-09-24 | 90 |
| K910674 | FLEXMEDICS MALLEABLE CANNULA | HRX | 1991-04-12 | 56 |
| K895899 | FLEXMEDICS GUIDEWIRE .012 ONLY | DQX | 1990-05-23 | 229 |
| K893626 | FLEXMEDICS GUIDEWIRE | DQX | 1989-09-26 | 138 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Flexmedics.
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 Flexmedics?
FDA lists 20 510(k) clearances under the applicant name “Flexmedics” (first 1986, latest 1999), across 9 product codes in 4 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 Flexmedics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Flexmedics is 56 days.
Which FDA product codes appear under Flexmedics?
The most frequent FDA product codes under this applicant name are EJF (Bracket, Metal, Orthodontic, 7); DQX (Wire, Guide, Catheter, 4); DZC (Wire, Orthodontic, 2).
Next steps
- See all 20 Flexmedics clearances with predicates and recalls
- Run predicate analysis for product code EJF, Flexmedics'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.