11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
FDA 510(k)
FDA Class 2
·Orthopedic
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
FDA 510(k)
FDA Class 3
·Cardiovascular
iCOR
FDA UDI
TELEFLEX INCORPORATED·09555342303926·Type 2
M2A-MAGNUM MOD HD SZ 48MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 2, 2019
DXTEND GLENOSPHERE STD D42MM
FDA Adverse Event
Injury
·DEPUY FRANCE·Product code KWS·December 6, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 16, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 12, 2011
LOCKING SCREW
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS·Product code HWC·June 17, 2008
STOCKERT CORONARY PERFUSION CANNULAE
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015