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

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SPINEART Navigation Instrument System

FDA 510(k)
FDA Class 2 ·Neurology

Vanguard® Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304271906·

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A183630150·18mm H x 36mm W x 30mm L x 15 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A183630120·18mm H x 36mm W x 30mm L x 12 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A18363080·18mm H x 36mm W x 30mm L x 8 degrees ALIF

CLUE MEDICAL AND CLUE MEDICAL BASIC

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA

FDA 510(k)
FDA Class 2 ·Radiology

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

UNKNOWN DEPUY ASR ACETABULAR CUP

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 22, 2013

COULTER LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 8, 2011

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

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

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024