510(k) K061317 ยท FSY Light, Surgical, Ceiling Mounted
ILED
| Applicant | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, Munchen, DE |
| Decision | Substantially Equivalent, Jun 22, 2006 |
| Received | May 11, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061317
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2015 | Trumpf Medical Systems, Inc. Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5 Completed |
FSY | None listed |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body w Terminated |
FSY | None listed |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patien Terminated |
FSY | None listed |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's bod Terminated |
FSY | None listed |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's bod Terminated |
FSY | None listed |
| Sep 5, 2012 | Trumpf Medical Systems, Inc. Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim.
The TRUMPF surgical lights are intended to locally illuminate an operatin Terminated |
FSY | None listed |
| Apr 1, 2009 | Trumpf Medical Systems, Inc. ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K Terminated |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.