17 results · 23ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Radiology

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

OPACIDEN OPA REAGENT STRIPS

FDA 510(k)
FDA Class 2 ·General Hospital

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code FRN·April 6, 2011

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORP·Product code MVK·May 24, 2013

NC QUANTUM APEX PTCA DILATATION CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 20, 2011

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

TERUMO RADIFOCUS GUIDE WIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2025

GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 23, 2023

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018

GMK-HINGE FEMORAL COMPONENT SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·February 7, 2022

GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2019

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019