Medical Device Manufacturer · DE , D 6367 Karben 2

Tracoe Medical GmbH - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1978

8

Total

8

Cleared

0

Denied

FDA 510(k) cleared devices by Tracoe Medical GmbH Anesthesiology ✕

8 devices

1-8 of 8

Cleared Aug 05, 2021

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