510(k) K010724 ยท FTD Lamp, Surgical
SOLA 700,SOLA 500, SOLA 300
| Applicant | Drager Medizintechnik GmbH, Telford PA, US |
| Decision | Substantially Equivalent, Jun 7, 2001 |
| Received | Mar 12, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010724
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2014 | Steris Corporation Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262. Terminated |
FSY | None listed |
| Nov 23, 2009 | Steris Corp STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm.
Intended for local illumination of the operating and examination area of the patient in treatment rooms. Terminated |
FTD | None listed |
| Sep 16, 2009 | Draeger Medical, Inc. Drager Surgical Lights Sola 500 and Sola 700. Terminated |
FTD | None listed |
| Jan 22, 2004 | Draeger Medical, Inc. Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp Terminated |
FTD | None listed |
| Jan 22, 2004 | Draeger Medical, Inc. Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp Terminated |
FTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.