22 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIPAP PRO BI-LEVEL SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040011515·Zirlux 16+ D2 95X12
INSET
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·November 26, 2025
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033321812·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033321843·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033321805·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033321836·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033321829·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033321850·
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·August 17, 2022
MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
FDA 510(k)
FDA Class 2
·Anesthesiology
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 26, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 19, 2025
HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR
FDA Adverse Event
Malfunction
·I-FLOW CORP.·Product code MEB·July 9, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·March 19, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 4, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 10, 2008
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018