27 results · 27ms · Sources: EU EUDAMED, US FDA

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Invisalign System

FDA 510(k)
FDA Class 2 ·Dental

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A143630150·14mm H x 36mm W x 30mm L x 15 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A14363080·14mm H x 36mm W x 30mm L x 8 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A143630120·14mm H x 36mm W x 30mm L x 12 degrees ALIF

DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA

FDA 510(k)
FDA Class 2 ·Radiology

FRESENIUS LIBERTY CYCLER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·June 3, 2011

GLENOID DIA 36

FDA Adverse Event
Injury ·DEPUY FRANCE, S.A.·Product code KWS·August 28, 2008

BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·December 5, 2020

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

INTIMA II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·October 31, 2018

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