Smith & Nephew Dyonics, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Smith & Nephew Dyonics, Inc.” (first 1990, latest 1996), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 74 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 | 14 | 14 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
Review panels
- Orthopedic (16)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (1)
- General Hospital (1)
- Obstetrics and Gynecology (1)
Most recent Smith & Nephew Dyonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955914 | LIMITED REUSE ARTHROSCOPIC BLADES | HRX | 1996-02-08 | 55 |
| K954627 | ECTRA II LIGAMENT RELEASE SYSTEM | HRX | 1995-12-18 | 73 |
| K954989 | DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES | ERL | 1995-11-27 | 27 |
| K953695 | DYONICS DISPOSABLE ARTHROSCOPIC BLADES | HRX | 1995-09-15 | 38 |
| K953387 | ECTRA LIGAMENT RELEASE SYSTEM | HRX | 1995-08-09 | 21 |
| K945182 | DYONICS FIXATION SCREWS | HWC | 1995-01-24 | 92 |
| K936071 | SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE | HET | 1994-08-19 | 242 |
| K934299 | DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION | HRX | 1994-02-14 | 165 |
| K920267 | DYONICS ARTHROSCOPIC KIT | LRO | 1993-03-23 | 427 |
| K922176 | INTELIJET SUCTION SUPPLY | BTA | 1992-11-18 | 194 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Smith & Nephew 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Smith & Nephew, Inc. (547 510(k)s)
- Smith & Nephew Richards, Inc. (87 510(k)s)
- Smith & Nephew United, Inc. (34 510(k)s)
- Smith & Nephew Medical Limited (20 510(k)s)
- Smith & Nephew Endoscopy, Inc. (18 510(k)s)
- Smith and Nephew Donjoy, Inc. (15 510(k)s)
- Smith & Nephew Medical, Ltd. (12 510(k)s)
- Smith River Biologicals (12 510(k)s)
- Smith & Nephew Inc., Endoscopy Div. (10 510(k)s)
- Smith & Nephew, Inc., Orthopaedic Div. (10 510(k)s)
- Smith & Nephew Perry (10 510(k)s)
- Smith & Nephew, Mpl Division (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith & Nephew Dyonics, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Smith & Nephew Dyonics, Inc.” (first 1990, latest 1996), across 8 product codes in 5 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 Smith & Nephew Dyonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew Dyonics, Inc. is 74 days.
Which FDA product codes appear under Smith & Nephew Dyonics, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 14); HWC (Screw, Fixation, Bone, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 22 Smith & Nephew Dyonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Smith & Nephew 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.