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

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Alinity i Rubella IgG

FDA 510(k)
FDA Class 2 ·Microbiology

ALINITY I RUBELLA IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 26, 2025

ALINITY I RUBELLA IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 7, 2025

ALINITY I RUBELLA IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·February 13, 2026

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA

LifeLens Wireless ECG Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

BISCOVER LV

FDA 510(k)
FDA Class 2 ·Dental

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·October 22, 2003

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

FDA Enforcement
Class II ·Terminated·Anodyne Surgical·June 23, 2021

ACCU-CHEK ULTRAFLEX INFUSION SET

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·November 7, 2008

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 31, 2011

ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

FDA Adverse Event
Malfunction ·HAEMONETICS CORP.·Product code CAC·July 18, 2013

44 CM (17") PUR EXT SET W/CLAVE® SPIKE, 0.2 ¿M FILTER AND BCV MLL

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 1, 2025

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

FDA Recall
Terminated ·Anodyne Surgical·Product code HMX·April 21, 2021