29 results · 34ms · Sources: EU EUDAMED, US FDA

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HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE

FDA 510(k)
FDA Class 2 ·Radiology

GORE TRI-LOBE BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)

FDA 510(k)
FDA Class 1 ·General Hospital

U-BLADE SET, TI GAMMA3 10.5X100MM

FDA Adverse Event
Injury ·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·May 29, 2013

NXSTAGE SYSTEM ONE

FDA Adverse Event
Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·June 9, 2011

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN BENNETT CORP.·Product code CBK·August 20, 2008

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022

FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2019

ACUPULSE

FDA Adverse Event
Injury ·LUMENIS LTD·Product code GEX·July 8, 2025

GMK SPHERE FEMORAL COMPONENT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 11, 2020

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2020

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 13, 2020

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2019

3005180920-2018-00587

FDA Adverse Event
Injury ·July 31, 2018

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 13, 2017

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 15, 2024