Radionics, A Division of Tyco Healthcare Group LP
Burlington, MA, US
Radionics, A Division of Tyco Healthcare Group LP appears in FDA device records in Burlington, MA. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Radionics, A Division of Tyco Healthcare Group LP between 2001 and 2005. The busiest year on record is 2001, with 3. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051947 | RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE | LFL | Substantially Equivalent | |
| K041997 | RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE | MUJ | Substantially Equivalent | |
| K032054 | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE | HAW | Substantially Equivalent | |
| K023519 | RADIONICS VARILINK 2 | IYE | Substantially Equivalent | |
| K021942 | RADIONICS POLE NEEDLES | GXI | Substantially Equivalent | |
| K013661 | XPLAN 2.2 WITH THE BODY SYSTEM | MUJ | Substantially Equivalent | |
| K012850 | RECORDING AND STIMULATING ELECTRODE | GZL | Substantially Equivalent | |
| K010548 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | HAW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain