9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EBNA IGG EIA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
K-WIRE
FDA UDI
Biomet Orthopedics, LLC·00880304480209·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122758·K-WIRE - SINGLE TROCAR THREADED 1.5mm DIA x 100mm
CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.
FDA 510(k)
FDA Class 2
·Neurology
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CAPSUREFIXNOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·February 9, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 23, 2014
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016