FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K093825 |
AMBU A/S |
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE |
01/13/2010 |
K071186 |
AMBU A/S |
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE |
07/30/2007 |
K152984 |
BIO PROTECH, INC. |
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes |
06/03/2016 |
K092973 |
BIONEN S.A.S. |
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE |
10/07/2010 |
K111131 |
CAREFUSION 209, INC. |
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES |
06/17/2011 |
K112034 |
CAREFUSION 209, INC. |
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES |
08/12/2011 |
K955335 |
CHALGREN ENTERPRISES, INC. |
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE |
01/29/1996 |
K982950 |
CHALGREN ENTERPRISES, INC. |
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 |
06/22/1999 |
K960591 |
CHALGREN ENTERPRISES, INC. |
RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP |
06/13/1996 |
K961013 |
MEDELEC INTL. CORP. |
DISPOSABLE NEEDLE ELECTRODE |
12/20/1996 |
K973442 |
MEDELEC, INC. D.B.A. TECA CORP. |
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES |
11/20/1997 |
K973444 |
MEDELEC, INC. D.B.A. TECA CORP. |
TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES |
11/20/1997 |
K001869 |
MEDICOTEST A/S |
DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE |
09/18/2000 |
K973529 |
MEDICOTEST A/S |
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES |
11/20/1997 |
K020907 |
MEDICOTEST A/S |
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES |
06/14/2002 |
K002992 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 |
08/15/2001 |
K990375 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 |
03/09/1999 |
K173815 |
Natus Manufacturing Limited |
Allergan Botox Needle Electrode |
06/29/2018 |
K143433 |
Natus Manufacturing Limited |
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm |
08/28/2015 |
K161430 |
Natus Manufacturing Limited |
Myoject Luer Lock Needle Electrode |
03/02/2017 |
K011818 |
NICOLET BIOMEDICAL, INC. |
STERILE EMG ELECTRODES |
09/06/2001 |
K120342 |
RHYTHMLINK INTERNATIONAL, LLC |
EMG RECORDING ELECTRODE ASSEMBLY |
06/22/2012 |
K091055 |
RHYTHMLINK INTERNATIONAL, LLC |
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R |
06/23/2009 |
K091056 |
RHYTHMLINK INTERNATIONAL, LLC |
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R |
06/23/2009 |
K080914 |
ROCHESTER ELECTRO MEDICAL, INC. |
ULTRASHARP CONCENTRIC NEEDLES |
07/15/2008 |
K981004 |
SPECIALIZED LABORATORY EQUIPMENT, LTD. |
SLE EMG ELECTRODES AND ACCESSORIES |
10/21/1998 |
K091410 |
SPES MEDICA S.R.L. |
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, |
08/11/2009 |
K062437 |
TECHNOMED EUROPE |
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED |
02/16/2007 |
K990015 |
TECHNOMED EUROPE |
ELECTRODE NEEDLES |
05/27/1999 |