19 results · 29ms · Sources: EU EUDAMED, US FDA

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REGIONAL OXIMETER SYSTEM, MODEL 7600

FDA 510(k)
FDA Class 2 ·Cardiovascular

LEONE SPA

FDA UDI
LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red

Medline

FDA UDI
MEDLINE INDUSTRIES, INC.·10884389028025·FENESTRATED DRAPE, 24 X 40 W/TAPE

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450213650·

STAR TOTAL ANKLE REPLACEMENT

FDA Adverse Event
Injury ·SMALL BONE INNOVATIONS, INC.·Product code NTG·July 24, 2014

FULL FACE MASK

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·September 9, 2011

MUSCLE STIMULATOR SA-100

FDA 510(k)
FDA Class 2 ·Physical Medicine

AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·May 2, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 15, 2014

ENTERALITE INFINITY ENTERAL FEEDING SET

FDA Adverse Event
Other ·MOOG MEDICAL DEVICES GROUP·Product code KNT·May 2, 2011

FULL FACE MASK

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code MNT·September 13, 2011

FULL FACE MASK

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code MNT·September 13, 2011

VARIPULSE¿ BI-DIRECTIONAL CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code QZI·September 3, 2025

THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·November 30, 2021

THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code LPB·July 7, 2023

ARCHITECT C4000

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·November 4, 2024

ALINITY I FREE T4 REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·October 28, 2024