33 results
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51ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Tempo Temporary Pacing Lead, Curved
FDA UDI
BIO TRACE MEDICAL·10866899000210·The BioTrace Medical Tempo Temporary Pacing Lea...
Tempo Temporary Pacing Lead
FDA UDI
BIO TRACE MEDICAL·10866899000203·The BioTrace Medical Tempo Temporary Pacing Lea...
ZOLL
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 8, 2021
RESPIRONICS
FDA Adverse Event
Malfunction
·Product code MNT·July 13, 2021
NIHON KOHDEN NKV-550
FDA Adverse Event
Malfunction
·NIHON KOHDEN ORANGEMED, LLC·Product code CBK·September 15, 2025
BD PYXIS¿ ANESTHESIA STATION ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·September 13, 2025
V60 VENTILATOR
FDA Adverse Event
Malfunction
·Product code MNT·January 8, 2021
Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. Novii Pod - The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Novii Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Novii Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
FDA Recall
Terminated
·MONICA HEALTHCARE LTD Interchange 25 Business Park Bostocks Lane Nottingham United Kingdom·Product code OSP·April 28, 2017
V60 VENTILATOR
FDA Adverse Event
Malfunction
·Product code MNT·December 10, 2020
BD PYXIS¿ ANESTHESIA STATION ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·April 21, 2025
LTV 1000 VENTILATOR
FDA Adverse Event
Injury
·VYAIRE MEDICAL, INC·Product code CBK·December 28, 2017
BD PYXIS¿ ES SERVER
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·January 2, 2026
LTV 1200 VENTILATOR
FDA Adverse Event
Death
·CAREFUSION, INC·Product code CBK·November 23, 2016
B8634, UROWIRE SIX PACK 6/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EZB·August 5, 2021
NIM EMG ENDOTRACHEAL TUBE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·May 12, 2014
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 27, 2010
B8634, UROWIRE SIX PACK 6/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EZB·August 2, 2021
BELLAVISTA
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL·Product code CBK·November 9, 2023
BIOTRACE TEMPO PACING LEAD
FDA Adverse Event
Injury
·BIOTRACE MEDICAL INC.·Product code LDF·September 25, 2018
BELLAVISTA
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL·Product code CBK·October 11, 2024