13 results · 21ms · Sources: EU EUDAMED, US FDA

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Align Lumbar Interbody Fusion System

FDA 510(k)
FDA Class 2 ·Orthopedic

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074362182·SCREW 7221535 HA COATED CANN 5.5 X 35

Uro-Cath® Molded-Latex Male External Catheter, 35mm with Urofoam®-2 & Uro-Prep®

FDA UDI
UROCARE PRODUCTS, INC.·00792293221551·These male external catheters are commonly refe...

Cerament Bone Void Filler

FDA 510(k)
FDA Class 2 ·Orthopedic

ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·February 2, 2022

MECTALIF ANT - LAG

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024

TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·November 5, 2008

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 24, 2011

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 9, 2013

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025