17 results · 35ms · Sources: EU EUDAMED, US FDA

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NICOLET BIOMEDICAL

FDA Adverse Event
Injury ·NICOLET BIOMEDICAL·Product code GXZ·July 1, 1997

DISPOSABLE SUBDERMAL NEEDLE

FDA Adverse Event
Malfunction ·NICOLET BIOMEDICAL·Product code GXY·April 16, 1997

NICOLET VIKING III

FDA Adverse Event
Malfunction ·NICOLET BIOMEDICAL·Product code GWF·August 2, 2004

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FDA Adverse Event
Malfunction ·NICOLET BIOMEDICAL·Product code GWQ·January 9, 2008

BRAVO MULTI MODALITY SYSTEM

FDA Adverse Event
Malfunction ·NICOLET BIOMEDICAL INC.·Product code GWQ·July 24, 2003

NICOLET SUBDERMAL NEEDLE

FDA Adverse Event
Malfunction ·NICOLET BIOMEDICAL, INC.·Product code GXE·June 28, 1996

VIKING II

FDA Adverse Event
Injury ·NICOLET BIOMEDICAL, INC.·Product code GWJ·March 10, 1995

(NICOLET) EEG VOYAGEUR

FDA Adverse Event
NICOLET BIOMEDICAL INC.·Product code GWQ·February 18, 2000

NICOLET

FDA Adverse Event
Malfunction ·NICOLET BIOMEDICAL INC·Product code JXE·May 29, 1998

NICOLET

FDA Adverse Event
Malfunction ·NICOLET BIOMEDICAL, INC.·Product code IKN·July 26, 1999

NICOLET NIC VUE

FDA Adverse Event
Malfunction ·CAREFUSION 209, INC.·Product code GWQ·December 9, 2009

DISPOSABLE SUBDERMAL NEEDLE PLATINA

FDA Adverse Event
Malfunction ·BIOMEDICAL DIV. NICOLET INSTRUMENTS·Product code IKT·June 7, 1995

BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne. Nicolet Biomedical, Inc.

FDA Recall
Terminated ·Nicolet Biomedical Div of Viasys Healthcare·Product code GWQ·July 17, 2007

BRAVO

FDA Adverse Event
Other ·NICOLET BIOMEDICAL (AKA VIASYS NEUROCARE; CARDINAL HEALTH 209)·Product code GWF·May 16, 2008

Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and 982A0422. Manufactured, designed, developed and marketed by VIASYS NeuroCare Inc., Madison, WI 53711

FDA Recall
Terminated ·Nicolet Biomedical Div of Viasys Healthcare·Product code GWQ·September 11, 2007

VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each box contains 10 pouches of Bar Electrodes and each pouch contains 10 electrodes

FDA Recall
Terminated ·Nicolet Biomedical Div of Viasys Healthcare·Product code GXZ·April 28, 2006

NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems.

FDA Recall
Terminated ·Nicolet Biomedical Div of Viasys Healthcare·Product code GWQ·August 25, 2006