41 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
FDA Recall
Terminated
·Product code HRY·April 22, 2011
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040014097·Zirlux 16+ C3 98.5X20
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033241127·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033241110·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033241080·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033241134·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033241097·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033241103·
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
FDA 510(k)
FDA Class 2
·Cardiovascular
PROFILE II ER
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 7, 2014
SCR REPLACEMENT SW-V GOLD COPING
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 19, 2017
SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 8, 2020
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·March 17, 2016
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·November 12, 2013
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 7, 2014
ACTIVA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code MHY·April 2, 2012
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·December 16, 2014