22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OIL FOR EMBRYO CULTURE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Phonak
FDA UDI
Phonak AG·07613275080856·Phonak Bolero Q70-SP (purple transparent)
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V·Product code FPA·November 17, 2025
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 23, 2015
SYNGO MULTIMODALITY WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
VECTOR TARGETING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 28, 2011
SCR REPLACEMENT SW-V GOLD COPING
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 19, 2017
INSET
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·November 7, 2025
SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 8, 2020
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 11, 2025
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 17, 2015
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·November 23, 2015
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·November 23, 2015
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 14, 2012
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·March 19, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 14, 2011
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code JCT·March 11, 2008
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 16, 2012
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