6 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).
FDA Enforcement
Class III
·Terminated·Cygnus Medical·April 20, 2016
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.
FDA Enforcement
Class III
·Terminated·Horiba Instruments, Inc dba Horiba Medical·April 10, 2013
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Enforcement
Class III
·Terminated·Theralase Inc.·December 11, 2019
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
FDA Enforcement
Class III
·Terminated·Advanced Bionics, LLC·February 26, 2020
HAMILTON-H900 Humidifier, Models: 950001, 950004
FDA Enforcement
Class III
·Completed·Hamilton Medical AG·July 20, 2022
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.
FDA Enforcement
Class III
·Terminated·GETINGE US SALES LLC·May 1, 2019