ClearanceBrief
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

CodeDeviceRecords
JEATable, Surgical With Orthopedic Accessories, Ac-Powered20
FSYLight, Surgical, Ceiling Mounted12
FQOTable, Operating-Room, Ac-Powered5
FWBCamera, Television, Surgical, Without Audio1
JEBTable, Surgical With Orthopedic Accessories, Manual1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 13, 2001K011693TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
Trumpf Medical Systems, Inc.
FSY

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 15, 2017Trumpf 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
FWBNone listed
Nov 10, 2016Trumpf 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
JEANone listed
Oct 5, 2016Trumpf 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
JEANone listed
Oct 5, 2016Trumpf 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
JEANone listed
Oct 5, 2016Trumpf 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
JEANone listed
Oct 5, 2016Trumpf 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
JEANone listed
Jan 19, 2016Trumpf 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
JEANone listed
Nov 2, 2015Trumpf Medical Systems, Inc.
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Completed
FSYK061317
K102758
Aug 7, 2015Trumpf 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
FSYK061317
Aug 7, 2015Trumpf 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
FSYK061317
Aug 7, 2015Trumpf 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
FSYK011693
Aug 7, 2015Trumpf 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
FSYK061317
Aug 7, 2015Trumpf 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
FSYK061317
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Jan 6, 2015Trumpf 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
JEANone listed
Oct 27, 2014Trumpf 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
JEANone listed
Dec 12, 2013Trumpf 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
FSYK011693
Nov 18, 2013Trumpf 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
JEBNone listed
Nov 5, 2013Trumpf Medical Systems
ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
Terminated
JEANone listed
Oct 18, 2012Trumpf 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
FSYK011693
Sep 5, 2012Trumpf 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
FSYK061317
Feb 13, 2012Trumpf 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
FSYK102758
Jan 11, 2012Trumpf Medical Systems, Inc.
OR table TITAN UT, Surgical Table. Surgical bed with Orthopedic Accessories.
Terminated
FQONone listed
Jan 11, 2012Trumpf Medical Systems, Inc.
OR table TITAN U, Surgical Table. Surgical bed with Orthopedic Accessories.
Terminated
FQONone listed
Jan 11, 2012Trumpf Medical Systems, Inc.
OR table TITAN T, Surgical Table. Surgical bed with Orthopedic Accessories.
Terminated
FQONone listed
Jan 11, 2012Trumpf Medical Systems, Inc.
OR table TITAN Automatic, Surgical Table. Surgical bed with Orthopedic Accessories.
Terminated
FQONone listed
Jan 11, 2012Trumpf Medical Systems, Inc.
OR table TITAN, Surgical Table. Surgical bed with Orthopedic Accessories.
Terminated
FQONone listed
Apr 1, 2009Trumpf Medical Systems, Inc.
ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
Terminated
FSYK061317
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