ClearanceBrief
Panels › Cardiovascular › Product code DRX · Class 2

Electrode, Electrocardiograph

Regulation 870.2360

0510(k)s in 12 months (329 all time)
0recalls in 12 months (20 all time)
19recalls that name a 510(k)
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Top companies in DRX

Company510(k)sRecalls
Graphic Controls Corp.170
Nikomed U.S.A., Inc.120
Lectec Corp.110
Labeltape Meditect, Inc.100
Leonhard Lang Co.100
Andover Medical, Inc.80
Arbo Medical, Inc.70
S & W Medico Teknik70
3M Company - Health Care Business06
Conmed Andover Medical, Inc.60
Decided510(k)Device and applicantCode
Aug 28, 1991K912450TRACETS SME 5000
Lectec Corp.
DRX
Aug 15, 1991K910139VER-MED A10014 RESTING EKG ELECTRODE & A10021
Vermont Medical, Inc.
DRX
Jul 25, 1991K912714RT40 RADIO TRANSLUCENT
Bio-Detek, Inc.
DRX
Jun 21, 1991K911990ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.
Somnitec, Inc.
DRX
Apr 22, 1991K910494RESTING EKG ELECTRODE SERIES
Medtronic Andover Medical, Inc.
DRX
Mar 21, 1991K905489VER-MED A10017 UNIVERSAL ELECTRODE
Vermont Medical, Inc.
DRX
Feb 7, 1991K905729CANMED 451
Andover Medical, Inc.
DRX
Feb 5, 1991K905446MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE
Medtronic Andover Medical, Inc.
DRX
Jan 31, 1991K904512TRACET AG 4000
Lectec Corp.
DRX
Dec 17, 1990K903491MONITRODE
Lleventon, ES
DRX
Nov 5, 1990K903555ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.
Jason Marketing Co.
DRX
Oct 31, 1990K904185SENSATRACE
Ludlow Corp., Technical Papers Division
DRX
Oct 31, 1990K903918MODEL 1850 ELECTRODE
Medtronic Vascular
DRX
Sep 4, 1990K902738ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH
Labeltape Meditect, Inc.
DRX
Sep 4, 1990K902176SILVER MACTRODE
Marquette Electronics, Inc.
DRX
Jul 31, 1990K902407NF-50-E DISPOSABLE ECG ELECTRODE
Medicotest, Inc.
DRX
Jul 18, 1990K902080RED DOT 2269 INFANT MONITORING ELECTRODE
3M Company
DRX
Jul 18, 1990K901555MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
Medtronic Vascular
DRX
Mar 19, 1990K900519CLASSIC ECG/STIMULATING NO. 1700 SERIES
Classic Medical Products, Inc.
DRX
Jan 18, 1990K896569ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC.
Jason Marketing Co.
DRX
Dec 13, 1989K896155RED DOT CARDIAC SENSOR SYSTEM
3M Company
DRX
Nov 3, 1989K895834BABY MAC ELECTROCARDIOGRAPH ELECTRODE
Marquette Electronics, Inc.
DRX
Oct 26, 1989K894991ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.
Labeltape Meditect, Inc.
DRX
Oct 12, 1989K894462CARE DISP. DIAG. ELECTRODES, SILVER/SILVER
Labeltape Meditect, Inc.
DRX
Oct 3, 1989K894920SELECTRODE
S & W Medico Teknik, DK
DRX
Sep 13, 1989K894679ELECTROTRACE DISP. RESTING EKG ELECTRODES
Jason Marketing Co.
DRX
Sep 5, 1989K894648ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO
Arbo Medical, Inc.
DRX
Sep 5, 1989K894562ARBO H79P DISPOSABLE MONITORING ELECTRODES
Arbo Medical, Inc.
DRX
Jul 14, 1989K893425VITATRACE
Lectec Corp.
DRX
Jun 20, 1989K893245L30-LB- INFANT LIMB BAND
Contour Electrodes, Inc.
DRX
May 1, 1989K884980F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
S & W Medico Teknik, DK
DRX
Mar 22, 1989K891075BARD NEONATAL ECG MONITORING ELECTRODE
C.R. Bard, Inc.
DRX
Mar 15, 1989K890201RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
Medtronic Vascular
DRX
Mar 10, 1989K884982M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
S & W Medico Teknik, DK
DRX
Mar 10, 1989K884981F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
S & W Medico Teknik, DK
DRX
Mar 9, 1989K884984M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
S & W Medico Teknik, DK
DRX
Mar 9, 1989K884983M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
S & W Medico Teknik, DK
DRX
Feb 23, 1989K885306NUPREP
Weaver & Co.
DRX
Feb 6, 1989K884775ARBO PINK H82P
Arbo Medical, Inc.
DRX
Jan 25, 1989K885262POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
Valleylab, Inc.
DRX
Jan 24, 1989K890103BARD TAB ECG MONITORING ELECTRODE
C.R. Bard, Inc.
DRX
Nov 17, 1988K883643TDK ECG ELECTRODE, MEL-10L
Tdk Corp., JP
DRX
Oct 6, 1988K884064BARD MULTI-TAC ECG MONITORING ELECTRODE
C.R. Bard, Inc.
DRX
Oct 5, 1988K882904TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5
Tdk Corp., JP
DRX
Jul 20, 1988K882216SYNCOR (R) MODEL S-801 ECG ELECTRODE
Lectec Corp.
DRX
Apr 11, 1988K881085SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE
Contour Electrodes, Inc.
DRX
Jan 28, 1988K875041FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE
Labeltape Meditect, Inc.
DRX
Jan 28, 1988K875015TRACETS 3000
Lectec Corp.
DRX
Jan 28, 1988K874562SECURATRODE
Meddev International Corp.
DRX
Jan 28, 1988K874424PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
Hewlett-Packard Co.
DRX

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