29 results · 26ms · Sources: EU EUDAMED, US FDA

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CADWELL SPIKE AND SEIZURE DETECTOR

FDA 510(k)
FDA Class 2 ·Neurology

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK

MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130

FDA 510(k)
FDA Class 2 ·Cardiovascular

RAYSTATION VERSION 1.0

FDA 510(k)
FDA Class 2 ·Radiology

DURAGEN PLUS ADHESION BARRIER MATRIX 3X3, 5 PACK

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·October 25, 2019

TORNIER SIMPLICITI NUCLEUS SIZE 2

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·October 20, 2025

TORNIER SIMPLICITI NUCLEUS SIZE 2

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·June 10, 2025

TORNIER SIMPLICITI NUCLEUS SIZE 2

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·February 24, 2026

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 31, 2013

IQ

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code DQX·June 23, 2011

COBAS E411 DISK SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 28, 2008

TORNIER SIMPLICITI NUCLEUS SIZE 1

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·April 16, 2026

TORNIER SIMPLICITI NUCLEUS SIZE 2

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·March 3, 2026

TORNIER SIMPLICITI NUCLEUS SIZE 2

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·March 3, 2026

TORNIER SIMPLICITI NUCLEUS SIZE 1

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·January 2, 2025

TORNIER SIMPLICITI NUCLEUS SIZE 1

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·January 2, 2025

BD PLASTIPAK¿ SYRINGE LUER-LOK¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 5, 2018

TORNIER SIMPLICITI NUCLEUS SIZE 1

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·January 8, 2023

TORNIER SIMPLICITI NUCLEUS SIZE 1

FDA Adverse Event
Injury ·TORNIER INC·Product code PKC·May 26, 2025