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

Ivy Biomedical Systems, Inc. has 27 FDA 510(k) cleared cardiovascular devices. Based in Branford, US.

Latest FDA clearance: Sep 2024. Active since 1986.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

27 devices
1–12 of 27
RT Carbon ECG Leads
K240087 · DSA Cable, Transducer And Electrode, Patient, (including Connector) · Cardiovascular
Sep 2024 246d
Cardiac Trigger Monitor
K202138 · DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · Cardiovascular
May 2021 287d
MRI PPG Patient Cable
K203653 · LNH System, Nuclear Magnetic Resonance Imaging · Radiology
Mar 2021 77d
MRI ECG Patient Cable
K192852 · LNH System, Nuclear Magnetic Resonance Imaging · Cardiovascular
Mar 2020 177d
MR Wireless Gating System, Model WGS-100
K171778 · LNH System, Nuclear Magnetic Resonance Imaging · Radiology
Mar 2018 272d
Cardiac Trigger Monitor
K170828 · DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · Cardiovascular
May 2017 58d
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
K151781 · DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · Cardiovascular
May 2016 331d
CARDIAC TRIGGER MONITOR
K110987 · DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · Cardiovascular
Jul 2011 105d
MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
K091787 · DQA Oximeter · Anesthesiology
Oct 2009 114d
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
K091985 · DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · Cardiovascular
Jul 2009 22d
CARDIAC TRIGGER, MODEL: CTM300
K083854 · DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · Cardiovascular
Feb 2009 51d
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
K023616 · DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · Cardiovascular
Nov 2002 6d
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