6 results
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48ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
FDA Recall
Open, Classified
·Powers Medical Devices, LLC·Product code HCC·October 1, 2015
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
FDA Recall
Open, Classified
·Zyno Medical LLC·Product code FRN·June 4, 2024
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Recall
Open, Classified
·Osteomed, LLC·Product code KMW·October 28, 2021
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·February 28, 2022
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·February 28, 2022
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·February 28, 2022