23 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
FDA 510(k)
FDA Class 2
·Hematology
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code PDJ·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
BD SAFETYGLIDE¿ INSULIN SYRINGE, THIN WALL; 30GX8MM
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·August 22, 2016
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH
FDA 510(k)
FDA Class 1
·General Hospital
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PREMIUM PLUS CEEA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·April 19, 2018
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·April 5, 2011
HARMONIC ACE 23CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 22, 2008
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LLZ·September 19, 2013