18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVIA CHEMISTRY FERRITIN (FRT) METHOD
FDA 510(k)
FDA Class 2
·Immunology
LuxaPost
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1107361·Drill for LuxaPost Ø 1.5 mm. Content: 1 drill (...
ADVIA Centaur® T4
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414177052·T4 Total - CENTAUR - RGT - 500 tests
Current®
FDA UDI
ST. JUDE MEDICAL, INC.·05414734502184·Tiered-therapy cardioverter/defibrillatorVVEV VVIR
Posted Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90911073615·.017 X .025 POSTED SS RIGHT FORM WIRES 36MM (10)
NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED
FDA 510(k)
FDA Class 2
·General Hospital
KIRSCHNER AND GUIDE WIRES
FDA 510(k)
FDA Class 2
·Orthopedic
PASS LP - LIGAPASS
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code JDQ·April 26, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 16, 2014
UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 1, 2011
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
CUSTOM TRANSDUCER MONITORING KIT
FDA Adverse Event
Other
·ICU MEDICAL, INC.·Product code DQO·January 10, 2013
REVITAN, RASP, DISTAL, CURVED, 14/140
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 11, 2018
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
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