17 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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RESMED HOSPITAL NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
RMO
FDA UDI
Rmo, Inc.·00885797100054·ORTHO IMPRESSION TRAY KIT ASST OF 10 , MX/MN TRAYS
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 19, 2025
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
OLYMPUS SCISSORS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code KNS·March 12, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 18, 2011
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·May 9, 2008
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013