Smith & Nephew Dyonics, Inc.
Andover, MA, US
Smith & Nephew Dyonics, Inc. appears in FDA device records in Andover, MA. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Smith & Nephew Dyonics, Inc. between 1990 and 1996. The busiest year on record is 1990, with 6. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 6 |
| 1991 | 2 |
| 1992 | 5 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 5 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K955914 | LIMITED REUSE ARTHROSCOPIC BLADES | HRX | Substantially Equivalent | |
| K954627 | ECTRA II LIGAMENT RELEASE SYSTEM | HRX | Substantially Equivalent for Some Indications | |
| K954989 | DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES | ERL | Substantially Equivalent | |
| K953695 | DYONICS DISPOSABLE ARTHROSCOPIC BLADES | HRX | Substantially Equivalent | |
| K953387 | ECTRA LIGAMENT RELEASE SYSTEM | HRX | Substantially Equivalent | |
| K945182 | DYONICS FIXATION SCREWS | HWC | Substantially Equivalent for Some Indications | |
| K936071 | SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE | HET | Substantially Equivalent | |
| K934299 | DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION | HRX | Substantially Equivalent | |
| K920267 | DYONICS ARTHROSCOPIC KIT | LRO | Unknown | |
| K922176 | INTELIJET SUCTION SUPPLY | BTA | Substantially Equivalent | |
| K914963 | SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET | HRX | Substantially Equivalent | |
| K913401 | SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL | HRX | Substantially Equivalent | |
| K914559 | SMALL JOINT SYSTEM | HRX | Substantially Equivalent | |
| K914919 | SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM | GCJ | Substantially Equivalent | |
| K913347 | PALMER ARCH SUPPRESSOR | HRX | Substantially Equivalent | |
| K912453 | INTELIJET TM FLUID MANAGEMENT SYSTEM | HRX | Substantially Equivalent | |
| K904284 | ARTHROSCOPIC SURGICAL BLADE | HRX | Substantially Equivalent | |
| K903620 | MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM | HRX | Substantially Equivalent | |
| K903193 | SMITH & NEPHEW DYONICS LEVELERT SYSTEM | FLN | Substantially Equivalent | |
| K901765 | POSTEROMEDIAL GUIDE | HRX | Substantially Equivalent | |
| K901616 | CANNULATED INTERFERENCE SCREW SYSTEM | HWC | Substantially Equivalent | |
| K901505 | ARTHROSCOPIC ELECTROSURGICAL PROBE | HRX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HRXArthroscope
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- LROGeneral Surgery Tray
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- FLNMonitor, Electric For Gravity Flow Infusion Systems
- BTAPump, Portable, Aspiration (Manual Or Powered)
- HWCScrew, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Smith & Nephew Dyonics, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Smith & Nephew Dyonics, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain