12 results
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20ms
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Sources: EU EUDAMED, US FDA
CDL ISOTONIC DILUENT
FDA 510(k)
FDA Class 1
·Hematology
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18225011·
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788225010·Cervical Trial 6x14x12, 12 deg Lordotic
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2019
AEI DR. TERAUCHI ULTRASONIC TIPS
FDA 510(k)
FDA Class 2
·Dental
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 21, 2014
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·November 2, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·August 26, 2010
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781270
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018