213 results
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72ms
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Sources: EU EUDAMED, US FDA
OmniPro System
FDA UDI
Mays & Asscoiates·B62536083000·The OmniAmp EEG Module is an amplifier system f...
OmniPro System
FDA UDI
Mays & Asscoiates·B62571884000·OmniPro PSG System used in PSG physiological da...
OmniPro System
FDA UDI
Mays & Asscoiates·B62536084100·The OmniAmp Interface Module is an amplifier in...
OmniPro System
FDA UDI
Mays & Asscoiates·B62536084000·The OmniAmp is an amplifier system for use in p...
OmniPro System
FDA UDI
Mays & Asscoiates·B62571883000·OmniPro EEG System used in EEG physiological da...
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·December 26, 2018
BURKE L. MAYS AND ASSOCIATES, INC.
FDA registration
BURKE L. MAYS AND ASSOCIATES, INC.·2 products·🇺🇸 United States
OMNIPRO
FDA Adverse Event
Other
·BURKE L. MAYS AND ASSOCIATES, INC.·Product code GWQ·March 8, 2012
C6 MCOT UNIVERSAL PATCH
FDA Adverse Event
Injury
·BRAEMAR MANUFACTURING, LLC·Product code DSI·February 17, 2023
ENDOTAK C
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 14, 2005
ENDOTAK SQ ARRAY
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 14, 2005
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 2, 2026
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 14, 2010
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 15, 2010
JUVEDERM ULTRA XC 1 ML ROW
FDA Adverse Event
Injury
·ALLERGAN (PRINGY)·Product code LMH·December 16, 2019
UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT
FDA Adverse Event
Injury
·BRAEMAR MANUFACTURING, LLC·Product code DSI·June 12, 2023
FLEXI-SEAL FMS
FDA Adverse Event
Injury
·CONVATEC·Product code MIP·March 18, 2010
ILET BIONIC PANCREAS
FDA Adverse Event
Injury
·BETA BIONICS INC.·Product code QFG·January 27, 2026
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·February 10, 2026
CENTRIMAG MOTOR, OUS
FDA Adverse Event
Injury
·THORATEC SWITZERLAND GMBH·Product code KFM·October 31, 2019