13 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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X-MESH EXPANDABLE CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606279·MIDMARK 7100 3" SOFTCARE
Conformis Hip System
FDA UDI
Conformis, Inc.·00850268007620·HANDLE, BROACH, NEUTRAL
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HDL CHOLESTEROL PLUS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 20, 2020
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2013
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SPINE LLC.·Product code NDN·May 6, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 17, 2008
RUNTHROUGH NS
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018
E-POLY TIBIAL BEARINGS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·July 12, 2017
RUNTHROUGH NS
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018
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