5 results
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10ms
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Sources: EU EUDAMED, US FDA
EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 19, 2020
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·February 28, 2018
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·February 28, 2018
Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340, 203-674, and 400-872, 2" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2" x 3.5" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Cutaneous electrode.
FDA Enforcement
Class II
·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Enforcement
Class II
·Terminated·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD·October 30, 2013