9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THYROTROPIN(TSH) ELISA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LAS-R TM
FDA 510(k)
FDA Class 2
·Immunology
OrthAlign Plus System
FDA 510(k)
FDA Class 2
·Neurology
NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 21, 2024
1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·August 22, 2018
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 6, 2013
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 27, 2011
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·July 31, 2014
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 4, 2020