69 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe

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

SPY INTRA-OPERATIVE IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

FINGERTIP PULSE OXIMETER MD300C

FDA 510(k)
FDA Class 2 ·Cardiovascular

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 25, 2023

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 3, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 1, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 28, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 6, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·August 18, 2025

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 20, 2026

T:SLIM G4 SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OYC·November 13, 2017

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 6, 2026

TELIGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 20, 2011

PLOYFORM SYNTHETIC MESH

FDA Adverse Event
Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·June 4, 2013

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 10, 2008

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 29, 2026

FREESTYLE PRECISION NEO

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 10, 2017