Tracoe Medical G M B H

FDA Filings

This page includes the latest FDA filings for Tracoe Medical G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8010485
FEI Number3003361161
NameLu Anne Bauer
Owner & OperatorTRACOE MEDICAL GMBH
Contact AddressReichelsheimer Str. 1/3 --
Nieder-Olm DE-RP Rheinland-Pfalz 55268 DE
Official Correspondent
  • STEPHAN - KOEHLER
  • 49-6136-91690-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address14 E Eau Claire St Unit 447
Rice Lake, WI 54868 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Tracoe medical GmbH
TRACOE® care 2023-06-26
Tracoe medical GmbH
TRACOE® care 2023-06-26
Tracoe medical GmbH
TRACOE® modular 2023-06-26
Tracoe medical GmbH
TRACOE silcosoft REF 373-3.5-C342023-06-23
Tracoe medical GmbH
TRACOE® twist plus 2023-06-23
Tracoe medical GmbH
TRACOE® twist plus 2023-06-23
Tracoe medical GmbH
TRACOE® twist plus 2023-06-23
Tracoe medical GmbH
TRACOE® twist 2023-06-23
Tracoe medical GmbH
TRACOE® twist 2023-06-23
Tracoe medical GmbH
TRACOE® twist 2023-06-23
Tracoe medical GmbH
TRACOE® twist 2023-06-23
Tracoe medical GmbH
TRACOE® mini 2022-01-28
Tracoe medical GmbH
TRACOE® mini 2022-01-28
Tracoe medical GmbH
TRACOE silcosoft REF 371-5.0-C602021-09-24
Tracoe medical GmbH
TRACOE® vario 2021-08-27
Tracoe medical GmbH
TRACOE® vario 2021-08-27
Tracoe medical GmbH
TRACOE® vario 2021-08-27
Tracoe medical GmbH
TRACOE® vario 2021-08-27
Tracoe medical GmbH
TRACOE® vario 2021-08-27
Tracoe medical GmbH
TRACOE® vario 2021-08-27
Tracoe medical GmbH
TRACOE® vario 2021-08-27
Tracoe medical GmbH
TRACOE® vario 2021-08-27
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-20
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
Tracoe medical GmbH
TRACOE® vario 2021-08-19
TRACOE Medical GmbH
TRACOE Vario2021-08-05
Tracoe medical GmbH
TRACOE® comfort n.a.2021-07-15
Tracoe medical GmbH
TRACOE® comfort 2021-06-17
Tracoe medical GmbH
TRACOE silcosoft REF 373-3.0-C452021-05-03
Tracoe medical GmbH
TRACOE experc Dilation Set REF 5202021-03-15
Tracoe medical GmbH
TRACOE® comfort 2021-03-08
Tracoe medical GmbH
TRACOE® care 2021-01-22
Tracoe medical GmbH
TRACOE® care 2021-01-22
Tracoe medical GmbH
TRACOE® care 2021-01-22
Tracoe medical GmbH
TRACOE® care 2021-01-22
Tracoe medical GmbH
TRACOE® care 2021-01-22
Tracoe medical GmbH
TRACOE® care 2021-01-22
Tracoe medical GmbH
TRACOE® care 2021-01-22
Tracoe medical GmbH
TRACOE® care 2021-01-22
Tracoe medical GmbH
TRACOE® care 2021-01-22
Tracoe medical GmbH
TRACOE® comfort 2021-01-19
Tracoe medical GmbH
TRACOE® comfort 2021-01-19
Tracoe medical GmbH
TRACOE® comfort 2020-10-23
Tracoe medical GmbH
TRACOE® comfort 2020-07-29
Tracoe medical GmbH
TRACOE® comfort 2020-04-10
Tracoe medical GmbH
TRACOE® comfort 2020-04-10
Tracoe medical GmbH
TRACOE® comfort 2020-01-13
Lu Anne Bauer [TRACOE MEDICAL GMBH]
Adhesive Carrier2019-12-20
Lu Anne Bauer [TRACOE MEDICAL GMBH]
Tracheal Compresses2019-12-20
Tracoe medical GmbH
TRACOE silcosoft REF 373-5.0-C602019-12-06
Tracoe medical GmbH
TRACOE® technic 2019-09-27
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE silcosoft Tracheostomy Tube2018-05-14
TRACOE Medical GmbH
TRACOE Silcosoft Tracheostomy Tube2018-04-27
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE cuff pressure monitor2017-01-13
TRACOE MEDICAL GMBH
TRACOE Cuff Pressure Monitor2016-12-21
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE smart Cuff Manager2016-11-11
TRACOE MEDICAL GMBH
TRACOE Smart Cuff Manager2016-09-27
Lu Anne Bauer [TRACOE MEDICAL GMBH]
Neck straps2014-04-07
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE mini Extension Piece2011-03-08
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE tube clean Cleaning Swabs2011-01-19
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE mini tracheostomy tube2008-04-16
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE stoma and grid buttons2008-03-05
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE comfort tubes and Accessory2007-12-06
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE-VARIO TRACHEOSTOMY TUBES2007-12-06
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE pure Tracheostomy Tubes2007-12-06
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE PHON ASSIST 12007-12-06
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE purofoam2007-07-23
Lu Anne Bauer [TRACOE MEDICAL GMBH]
PUROFOAM-AND GAUZE2007-07-23
TRACOE MEDICAL GMBH
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 4702005-10-25
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE twist & twist plus2005-03-24
TRACOE MEDICAL GMBH
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO2005-02-18
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE TRACH CLEANING2004-07-07
Lu Anne Bauer [TRACOE MEDICAL GMBH]
TRACOE HUMID ASSIST2003-01-03
TRACOE MEDICAL GMBH
TRACHEOSTOMY TUBES TRACOE-FLEX1996-09-13
TRACOE MEDICAL GMBH
TRACHEOTOMY TUBES1978-10-24

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