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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