11 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS
FDA 510(k)
FDA Class 2
·Cardiovascular
PICCOLO BASIC METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·October 22, 2020
PICCOLO COMPREHENSIVE METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·November 3, 2020
LARGE AO COUPLING ASNIS III HALL FITTING
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 25, 2012
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CASPIAN SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EARIGATOR
FDA Adverse Event
Malfunction
·SURYA TECHNOLOGIES INTERNATIONAL·Product code JYH·January 4, 2001
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·March 7, 2013
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·March 18, 2015