22 results · 24ms · Sources: EU EUDAMED, 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