Medical Device Manufacturer · US , Branford , CT

Ivy Biomedical Systems, Inc. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1986

27

Total

27

Cleared

0

Denied

FDA 510(k) cleared devices by Ivy Biomedical Systems, Inc. Cardiovascular ✕

20 devices

1-12 of 20

Cleared Sep 13, 2024

RT Carbon ECG Leads

Cardiovascular · 246d

Cleared May 14, 2021

Cardiac Trigger Monitor

Cardiovascular · 287d

Cleared Mar 28, 2020

MRI ECG Patient Cable

Cardiovascular · 177d

Cleared May 17, 2017

Cardiac Trigger Monitor

Cardiovascular · 58d

Cleared May 27, 2016

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor

Cardiovascular · 331d

Cleared Jul 22, 2011

CARDIAC TRIGGER MONITOR

Cardiovascular · 105d

Cleared Jul 24, 2009

UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE

Cardiovascular · 22d

Cleared Feb 13, 2009

CARDIAC TRIGGER, MODEL: CTM300

Cardiovascular · 51d

Cleared Nov 04, 2002

PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)

Cardiovascular · 6d

Cleared Aug 16, 1996

PATIENT MONITOR MODEL 405P

Cardiovascular · 255d

Cleared Jul 13, 1995

PARAMETERS MONITORES

Cardiovascular · 268d

Cleared Mar 01, 1991

Cardiovascular · 142d