13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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