77 results · 24ms · Sources: EU EUDAMED, US FDA

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Indigo Aspiration System - Aspiration Catheter 7 and Separator 7

FDA 510(k)
FDA Class 2 ·Cardiovascular

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·December 10, 2024

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·January 5, 2023

CERAROOT IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026

NEXTAR INFRARED CAMERA

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 14, 2011

TENDRIL STS

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

MW5030685

FDA Adverse Event
Injury ·June 21, 2013

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 9, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 26, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 3, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·March 9, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 27, 2026