Tracoe Medical GmbH is one of 471 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Tracoe Medical GmbH - FDA 510(k) Cleared Devices
Recent clearances: TRACOE vario, TRACOE silcosoft Tracheostomy Tube, TRACOE Cuff Pressure Monitor
8
Total
8
Cleared
0
Denied
Tracoe Medical GmbH has 8 FDA 510(k) cleared medical devices. Based in D 6367 Karben 2, DE.
Last cleared in 2021. Active since 1978. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Tracoe Medical GmbH Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Capamed, Inc. and Ajw Technology Consultants, Inc..
FDA 510(k) Regulatory Record - Tracoe Medical GmbH
8 devices
Cleared
Aug 05, 2021
TRACOE vario
Anesthesiology
262d
Cleared
Apr 27, 2018
TRACOE silcosoft Tracheostomy Tube
Anesthesiology
231d
Cleared
Dec 21, 2016
TRACOE Cuff Pressure Monitor
Anesthesiology
453d
Cleared
Sep 27, 2016
TRACOE smart Cuff Manager
Anesthesiology
363d
Cleared
Oct 25, 2005
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460,...
Anesthesiology
132d
Cleared
Feb 18, 2005
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST...
Anesthesiology
95d
Cleared
Sep 13, 1996
TRACHEOSTOMY TUBES TRACOE-FLEX
Anesthesiology
150d
Cleared
Oct 24, 1978
TRACHEOTOMY TUBES
Anesthesiology
14d