6 results · 7ms · Sources: EU EUDAMED, US FDA

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Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

FDA Enforcement
Class II ·Terminated·Physician Engineered Products, Inc.·September 9, 2015

Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013