26 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMAGECHECKER-CT WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197470759·Farrior Specula, oval
Ø 5.3x...
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
FDA 510(k)
FDA Class 2
·Cardiovascular
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
MINICAPS
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·December 22, 2023
CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
FDA Adverse Event
Malfunction
·HAEMONETICS CORPORATION·Product code CAC·July 9, 2024
ALLURA XPER FD
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·September 1, 2023
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 15, 2023
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 11, 2023
ALLURA XPER FD
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 10, 2023
INFUSOMAT®
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·January 23, 2025
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·March 27, 2013
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 24, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
MINICAP
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 28, 2023
EPOC BLOOD ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·EPOCAL INC.·Product code CHL·October 26, 2023
EPOC BLOOD ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·EPOCAL INC.·Product code CHL·October 26, 2023
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
FDA Recall
Terminated
·Radiometer America Inc·Product code LKD·September 27, 2011
MINICAPS
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 2, 2023
EPOC BLOOD ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·EPOCAL INC.·Product code CHL·October 26, 2023