40 results · 28ms · Sources: EU EUDAMED, US FDA

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MIO ADVANCE

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code FPA·July 20, 2021

MiniMed Mio Advance infusion set

FDA 510(k)
FDA Class 2 ·General Hospital

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·April 22, 2022

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·April 22, 2022

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 23, 2022

IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·June 24, 2022

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Injury ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 2, 2026

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 16, 2026

UNIFY ASSURA CRT-D

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 15, 2014

FLEXTEND

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·July 24, 2011

GYNECARE TVT OBURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·June 17, 2013

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 9, 2024

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 10, 2024

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 12, 2025

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 1, 2025

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 1, 2025

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 1, 2025

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 1, 2025