51 results
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40ms
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Sources: EU EUDAMED, US FDA
WAVi Co.
FDA UDI
WAVI CO.·B592WE200·
WAVi Co.
FDA UDI
WAVI CO.·B592WH400·
WAVi Co.
FDA UDI
WAVI CO.·B592WH300·
WAVi Co
FDA UDI
WAVI CO.·B592WH200·Small Headset
WAVi Co.
FDA UDI
WAVI CO.·B592WH500·
WAVi Co.
FDA UDI
WAVI CO.·B592WE100·
WAVI CO
FDA registration
WAVI CO·2 products·🇺🇸 United States
WAVi Electrical Processing Unit
FDA UDI
WAVI CO.·B592WD100·
WAVi Style Ear Clips
FDA UDI
WAVI CO.·B592WH801·
WAVi Scan Software
FDA UDI
WAVI CO.·B592SW100·
WAVi Scan Kit
FDA UDI
WAVI CO.·B592WK200·
ACS HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING
FDA Adverse Event
Malfunction
·GUIDANT ACS/DVI·Product code DQX·July 9, 1998
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS CVS DIV. BAXTER HEALTHCARE CORP.·Product code LWR·February 26, 1997
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).
FDA Recall
Open, Classified
·WAVi Co.·Product code GWQ·December 8, 2023
GLUCOMETER ELITE XL
FDA Adverse Event
Malfunction
·ARKRAY, INC.·Product code NBW·February 18, 2003
ASTATO XS 9-12
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·December 20, 2023
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).
FDA Enforcement
Class II
·Ongoing·WAVi Co.·June 12, 2024
ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE
FDA Adverse Event
Malfunction
·GUIDANT ACS/DVI·Product code DQX·December 19, 1997
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·February 18, 2011
DRAIN, FLAT, 10X4MM, PERFORATED
FDA Adverse Event
Malfunction
·ALLEGIANCE HEALTHCARE·Product code GCY·April 23, 1998