14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)
FDA 510(k)
FDA Class 2
·Dental
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
AVON PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
1823260-2017-01832
FDA Adverse Event
Malfunction
·August 28, 2017
BARRIGEL INJECTABLE GEL
FDA Adverse Event
Malfunction
·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024
COBAS 6000 E 601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 5, 2017
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 30, 2008
RINGLOC ACETABULAR LINER 22MM HI WALL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·August 23, 2011
ENDOPATH ETS 45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDW·July 8, 2013
COBAS 6000 CORE UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 12, 2017
1823260-2017-01311
FDA Adverse Event
Malfunction
·June 23, 2017
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·September 11, 2017
COBAS 6000 E 601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 27, 2017
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 28, 2014