133 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·June 12, 2018
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code GWJ·November 6, 2025
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Recall
Open, Classified
·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code OHQ·October 17, 2025
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Recall
Open, Classified
·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code OHQ·October 17, 2025
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·October 1, 2025
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
FDA Recall
Open, Classified
·IMPRIS Imaging Inc·Product code LNH·September 30, 2025
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
FDA Recall
Open, Classified
·IMPRIS Imaging Inc·Product code LNH·September 30, 2025
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
FDA Recall
Open, Classified
·IMPRIS Imaging Inc·Product code LNH·September 30, 2025
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
FDA Recall
Open, Classified
·IMPRIS Imaging Inc·Product code LNH·September 30, 2025
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
FDA Recall
Open, Classified
·Product code BYS·October 11, 2023
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
FDA Recall
Open, Classified
·Draegar Medical Systems, Inc.·Product code MHX·October 9, 2019
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
FDA Recall
Open, Classified
·Product code BYS·October 11, 2023
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
FDA Recall
Open, Classified
·CardioQuip, LLC·Product code DWC·May 12, 2021
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FJK·August 31, 2020
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
FDA Recall
Open, Classified
·CardioQuip, LLC·Product code DWC·May 12, 2021
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
FDA Recall
Open, Classified
·CardioQuip, LLC·Product code DWC·May 12, 2021