510(k) K013242 ยท FTD Lamp, Surgical
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
| Applicant | STERIS Corporation, Montgomery AL, US |
| Decision | Substantially Equivalent, Dec 13, 2001 |
| Received | Sep 28, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K013242
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2011 | Steris Corporation Harmony LA/LED Monitor Arm Adapter. Model Number: LB61
The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the moni Terminated |
FSY | None listed |
| Apr 1, 2010 | Steris Corporation Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391.
Designed to provide visible immunization of the surgical field or the patient and to Terminated |
FTD | None listed |
| Apr 1, 2010 | Steris Corporation Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393.
Designed to provide visible immunization of the surgical field or the patient and to Terminated |
FTD | None listed |
| Apr 1, 2010 | Steris Corporation Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086.
Designed to provide visible immunization of the surgical field or the patient and to provide Terminated |
FTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.