Carl Zeiss Surgical GmbH
North Attleboro, MA, US
Carl Zeiss Surgical GmbH appears in FDA device records in North Attleboro, MA. FDA records list 4 510(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
- 4
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 4 510(k) clearances for Carl Zeiss Surgical GmbH between 2005 and 2012. The busiest year on record is 2005, with 1. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110590 | INTRABEAM NEEDLE APPLICATOR | JAD | Substantially Equivalent | |
| K100468 | ZEISS INFRARED 800 WITH FLOW 800 OPTION | IZI | Substantially Equivalent | |
| K090584 | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS | JAD | Substantially Equivalent | |
| K051055 | INTRABEAM SYSTEM | JAD | 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