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 silcosoft REF 370-4.0-C382024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C652024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C602024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C552024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C502024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C452024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C422024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C382024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C362024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C342024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C322024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C302024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.5-C282024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C552024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C502024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C462024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C432024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C412024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C372024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C342024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C322024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C282024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C242024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-4.0-C362024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-4.5-C382024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-4.0-C342024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 373-5.0-C462024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-4.5-C402024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-3.5-C322024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-4.5-C382024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-3.5-C302024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-5.5-C482024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-4.5-C452024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-4.5-C402024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-4.5-C402024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-4.0-C362024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-3.5-C282024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-2.5-C282024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-2.5-C262024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-2.5-C282024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C302024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-2.5-C262024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-2.5-C302024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-3.0-C282024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-2.5-C262024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 373-3.0-C262024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-3.5-C322024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.0-C262024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-3.0-C262024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-4.0-C322024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-3.0-C302024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-3.0-C322024-10-16
Tracoe medical GmbH
TRACOE® mini 2024-10-16
Tracoe medical GmbH
TRACOE® mini 2024-10-16
Tracoe medical GmbH
TRACOE® mini 2024-10-16
Tracoe medical GmbH
TRACOE® comfort 2024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 373-5.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 373-5.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 373-4.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 373-4.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 373-3.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 373-3.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-3.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-3.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-4.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-4.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-5.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-5.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 373-2.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-5.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-5.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-4.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-4.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-3.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-3.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 372-2.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 371-2.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-5.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-5.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-4.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-4.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-3.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 370-2.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 363-4.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 363-3.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 363-3.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 363-2.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 362-4.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 362-3.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 362-3.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 362-2.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 361-4.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 361-3.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 361-3.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 361-2.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 360-4.02024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 360-3.52024-10-16
Tracoe medical GmbH
TRACOE silcosoft REF 360-2.52024-10-16
Tracoe medical GmbH
TRACOE® mini 2024-10-16
TRACOE Medical GmbH
TRACOE Vario2021-08-05
Lu Anne Bauer [TRACOE MEDICAL GMBH]
Adhesive Carrier2019-12-20
Lu Anne Bauer [TRACOE MEDICAL GMBH]
Tracheal Compresses2019-12-20
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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