22 results · 28ms · Sources: EU EUDAMED, 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