22 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
FDA 510(k)
FDA Class 2
·Orthopedic
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 2, 2026
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 22, 2008
LAMITRODE 44 SURGICAL LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 5, 2011
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
PIIC CLASSIC UPGRADE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 24, 2024
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
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014