322 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Navik 3D
FDA UDI
APN HEALTH·00869781000308·Navik 3D™ is a multi-component computer system ...
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 14, 2013
VIGILANT EL ICD DR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·March 5, 2025
INTERSTIM
FDA Adverse Event
Malfunction
·AVAILMED S.A.DE C.V.9·Product code EZW·July 18, 2019
AVANOS MEDICAL, INC.
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code BTR·June 5, 2025
CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·March 2, 2023
Navik 3D v2, REF NAVIK3D, 3D Mapping System
FDA Recall
Open, Classified
·APN Health LLC·Product code DQK·November 7, 2023
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·March 13, 2018
Navik 3D v2, REF NAVIK3D, 3D Mapping System
FDA Enforcement
Class III
·Ongoing·APN Health LLC·December 20, 2023
UNKNOWN EXTERNAL NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·June 15, 2012
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 12, 2018
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 16, 2014
APQ HEALTH INC
FDA registration
APQ HEALTH INC·1 product·🇺🇸 United States
Autoplaque
FDA UDI
APQ HEALTH INC.·00860014730009·Autoplaque software performs post-processing o...
SHIELD GLOVES
FDA Adverse Event
Other
·APO HEALTH·Product code LYY·January 21, 1994
EVERSENSE SENSOR
FDA Adverse Event
Injury
·SENSEONICS INC.·Product code SBA·February 2, 2026
GEL-SALINE MAMMARY IMPLANT
FDA Adverse Event
Injury
·MCGHAN MEDICAL CORPORATION·Product code FTR·August 12, 1998
EMBLEM S-ICD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·April 17, 2025
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 9, 2016
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 28, 2016