20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ALAMAR ANTIBIOTIC SUSCEPTIBILITY
FDA 510(k)
FDA Class 2
·Microbiology
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
FDA 510(k)
FDA Class 1
·Microbiology
ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
FDA 510(k)
FDA Class 2
·Microbiology
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code GEX·July 14, 2022
VISUALASE
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code GEX·March 21, 2023
ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LLC - ALCON PRECISION DEVICE·Product code HMX·December 1, 2022
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·August 11, 2017
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
FDA Enforcement
Class II
·Terminated·CareFusion 303, Inc.·March 29, 2017
ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LLC - ALCON PRECISION DEVICE·Product code HMX·March 28, 2022
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
FDA Recall
Terminated
·CareFusion 303, Inc.·Product code FRN·November 1, 2016
PROSTAPROBE
FDA Adverse Event
Malfunction
·EDAP TECHNOMED, SA/PARC D"ACTIVITIES LA POUD-LAMAR·Product code MEQ·April 14, 2000
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 19, 2024
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 19, 2024
Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood pressure, respiration, continuous temperature and IV Drug Calculations. Optional digital displays are provided for invasive blood pressure (up to four) anesthetic agents, O2 and NO2, ST, and CO2.
FDA Recall
Terminated
·Datascope Corp·Product code DRT·September 7, 2005
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 19, 2024
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 19, 2024
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 19, 2024
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 19, 2024
Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 19, 2024
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
FDA Recall
Completed
·Fresenius Medical Care Holdings, Inc.·Product code FKX·September 12, 2020