Deltex Medical Limited is one of 462 FDA 510(k) medical device manufacturers from United Kingdom in the dataset, ranked by real submission volume.
Deltex Medical Limited - FDA 510(k) Cleared Devices
Recent clearances: Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+, Deltex Medical KDP72 Doppler Probe
6
Total
6
Cleared
0
Denied
Deltex Medical Limited has 6 FDA 510(k) cleared medical devices. Based in Stevenage, Hertfordshire, GB.
Historical record: 6 cleared submissions from 2009 to 2018. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Deltex Medical Limited Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Meddiquest Limited as regulatory consultant.
FDA 510(k) Regulatory Record - Deltex Medical Limited
6 devices
Cleared
Jun 28, 2018
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
Cardiovascular
318d
Cleared
Jul 24, 2015
Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
Cardiovascular
163d
Cleared
Jan 22, 2015
Deltex Medical KDP72 Doppler Probe
Cardiovascular
105d
Cleared
Oct 10, 2013
DELTEX MEDICAL CARDIOQ-EDM+
Cardiovascular
91d
Cleared
Oct 20, 2011
DELTEX MEDICAL CARDIOQ EDM
Cardiovascular
140d
Cleared
Jan 29, 2009
I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE...
Cardiovascular
405d