Dyonics, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Dyonics, Inc.” (first 1978, latest 1990), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 51 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Smith+Nephew, based on public ownership records.
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 |
|---|---|---|---|
| HRX | Arthroscope | 8 | 8 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | 3 | 3 |
| BWN | Table And Attachments, Operating-Room | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| HST | Apparatus, Traction, Non-Powered | 1 | 1 |
| HTR | Rasp | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 1 |
| LXI | Guide, Drill, Ligament | 1 | 1 |
| LYH | Arthrometer | 1 | 1 |
Review panels
- Orthopedic (14)
- Neurology (3)
- General and Plastic Surgery (2)
Most recent Dyonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900070 | MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM | HRX | 1990-02-16 | 43 |
| K896416 | DYONICS SHOULDER PORTAL SYSTEM | HRX | 1990-01-02 | 55 |
| K893136 | SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY | HRX | 1989-12-14 | 233 |
| K890665 | MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES | HRX | 1989-11-03 | 267 |
| K894728 | DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE | HRX | 1989-08-18 | 23 |
| K892062 | PS3500 ARTHROSCOPIC SURGICAL SYSTEM | HRX | 1989-06-23 | 85 |
| K884839 | MODIFIED SAW BLADES TO THE SAGITAL SAW | KIJ | 1988-12-07 | 16 |
| K881876 | DYNAMIC CRUCIATE TESTER | LYH | 1988-11-17 | 197 |
| K880739 | DYONICS DRILL GUIDE/ISOMETER SYSTEM | LXI | 1988-03-21 | 26 |
| K880150 | PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM | HWE | 1988-03-04 | 51 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dyonics, Inc..
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 Dyonics, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Dyonics, Inc.” (first 1978, latest 1990), across 10 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 Dyonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dyonics, Inc. is 51 days.
Which FDA product codes appear under Dyonics, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 8); KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment, 3); BWN (Table And Attachments, Operating-Room, 1).
Next steps
- See all 19 Dyonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Dyonics, 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.