55 results · 22ms · Sources: EU EUDAMED, US FDA

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VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

n/a

FDA UDI
Ortho Development Corporation·00822409072293·DAA Modular Canal Finder

HSB - Cement Burn Component

FDA UDI
Certified Safety Manufacturing, Inc.·00766588121178·HSB - Cement Burn Component

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0101170·Distractor, Smooth Paddle, Lordotic, 17mm

MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS

FDA 510(k)
FDA Class 2 ·General Hospital

GUIDANT AXIUS CORONARY SHUNT

FDA 510(k)
FDA Class 2 ·Cardiovascular

CUSTOM TUBING - SET INC. OXYGENATOR

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·April 24, 2015

QUADROX COMPLETE PACK

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 24, 2014

HLM TUBING SET W/SOFTLINE COATING

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DWF·July 13, 2015

QUADROX-I HMO 70000+VHK70000

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 7, 2015

ECAREMANAGER V3.6

FDA Adverse Event
Malfunction ·VISICU·Product code MSX·September 21, 2009

HMO 71000-J#QUADROX-1 ADULT + FILTER

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 3, 2015

HLM TUBING SET W/SOFTLINE COATING

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DWF·July 16, 2015

HQC 16602-3#HL-SET, OFFENES SYSTEM

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·December 19, 2014

ECAREMANAGER V3.6

FDA Adverse Event
Malfunction ·VISICU·Product code MSX·December 14, 2009

DESCRIPTION FROM THE CUSTOMER REPORT:

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 19, 2016

QUADROX-I ADULT WITH INTEGRATED FILTER

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 17, 2016

CUSTOM TUBING - SET INCL. HMO 71000

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·April 14, 2015

QUATTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 13, 2013

FLEXICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·March 9, 2011