9 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
FDA Enforcement
Class I
·Terminated·Galemed Corporation·January 1, 2020
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
FDA Enforcement
Class I
·Terminated·TELEFLEX-MORRISVILLE·November 13, 2019
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
FDA Enforcement
Class I
·Terminated·Galemed Corporation·January 1, 2020
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
FDA Enforcement
Class I
·Terminated·Galemed Corporation·January 1, 2020
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
FDA Enforcement
Class I
·Ongoing·NOXBOX LTD·October 15, 2025
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·December 20, 2023
e600 Automatic Transport Ventilator, Model Number 01EVE600
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
e500 Automatic Transport Ventilator, Model Number 01EVE500
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
e700 Automatic Transport Ventilator, Model Number 01EVE700
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019