Company ยท US
Trumpf Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2001. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
38recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2017 | Trumpf Medical Systems, Inc. Camera System, Television, Surgical without audio
Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching. Terminated |
FWB | None listed |
| Nov 10, 2016 | Trumpf Medical Systems, Inc. OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798 Terminated |
JEA | None listed |
| Oct 5, 2016 | Trumpf Medical Systems, Inc. Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786
Patient positioning during surgery, ranging from anesthesia induction to actu Terminated |
JEA | None listed |
| Oct 5, 2016 | Trumpf Medical Systems, Inc. Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878
Patient positioning during surgery, ranging from anesthesia induction to actual surgery Terminated |
JEA | None listed |
| Oct 5, 2016 | Trumpf Medical Systems, Inc. Stationary Column TruSystem 7599, Material Number 1717020
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transpo Terminated |
JEA | None listed |
| Oct 5, 2016 | Trumpf Medical Systems, Inc. Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to Terminated |
JEA | None listed |
| Jan 19, 2016 | Trumpf Medical Systems, Inc. Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems).
The shuttle is intended for the following applications: 1. Terminated |
JEA | None listed |
| 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 | K061317 K102758 |
| 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 | K061317 |
| 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 | K061317 |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patie Terminated |
FSY | K011693 |
| 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 | K061317 |
| 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 | K061317 |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesth Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from ane Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Pat Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anes Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthe Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesi Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from a Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthe Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesth Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery fro Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anest Terminated |
JEA | None listed |
| Oct 27, 2014 | Trumpf Medical Systems, Inc. TITAN Operating Room Table
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the p Terminated |
JEA | None listed |
| Dec 12, 2013 | Trumpf Medical Systems, Inc. Helion S Exam Light or H300
The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice. Terminated |
FSY | K011693 |
| Nov 18, 2013 | Trumpf Medical Systems, Inc. TruSystem Surgical Table (TS7000) Leg Section One Part Light HU
Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSyst Terminated |
JEB | None listed |
| Nov 5, 2013 | Trumpf Medical Systems ORBIT PT.
The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process. Terminated |
JEA | None listed |
| Oct 18, 2012 | Trumpf Medical Systems, Inc. Helion and Xenion surgical lights, 501/01 series KLM lights.
The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. Terminated |
FSY | K011693 |
| 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 | K061317 |
| Feb 13, 2012 | Trumpf Medical Systems, Inc. Surgical lighting systems iLED and TruLight in use with the ALC+ function.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a Terminated |
FSY | K102758 |
| Jan 11, 2012 | Trumpf Medical Systems, Inc. OR table TITAN UT, Surgical Table.
Surgical bed with Orthopedic Accessories. Terminated |
FQO | None listed |
| Jan 11, 2012 | Trumpf Medical Systems, Inc. OR table TITAN U, Surgical Table.
Surgical bed with Orthopedic Accessories. Terminated |
FQO | None listed |
| Jan 11, 2012 | Trumpf Medical Systems, Inc. OR table TITAN T, Surgical Table.
Surgical bed with Orthopedic Accessories. Terminated |
FQO | None listed |
| Jan 11, 2012 | Trumpf Medical Systems, Inc. OR table TITAN Automatic, Surgical Table.
Surgical bed with Orthopedic Accessories. Terminated |
FQO | None listed |
| Jan 11, 2012 | Trumpf Medical Systems, Inc. OR table TITAN, Surgical Table.
Surgical bed with Orthopedic Accessories. Terminated |
FQO | None listed |
| Apr 1, 2009 | Trumpf Medical Systems, Inc. ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K Terminated |
FSY | K061317 |