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

Decided510(k)Device and applicantCode
May 16, 1985K840445SYNKARA
Lectec Corp.
DRX
Apr 9, 1985K850132DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC
Consolidated Medical Equipment, Inc.
DRX
Apr 9, 1985K850130PRN ECG ELECTRODE
Consolidated Medical Equipment, Inc.
DRX
Mar 1, 1985K842514ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD
Multi Biosensors, Inc.
DRX
Mar 1, 1985K841944DISPOSABLE ECG ELECTRODE
Bristol Medical Electronics Corp.
DRX
Feb 27, 1985K850085DISPOSABLE ECG ELECTRODES EASATRACE
Medical Device Marketing
DRX
Feb 20, 1985K844856ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON
Bristol Medical Electronics Corp.
DRX
Jan 14, 1985K844632INFANT LIMB ELECTRODE
Sentry Medical Products, Inc.
DRX
Jan 2, 1985K844345CONTOUR ELECTRODE
Heuristic Medical Systems, Inc.
DRX
Jan 2, 1985K844335ELECTROCARDIOGRAPH ELECTRODE
Meditect
DRX
Dec 27, 1984K844100CANMED 101
Medtronic Vascular
DRX
Dec 27, 1984K844099CANMED 102
Medtronic Vascular
DRX
Oct 26, 1984K840646CARDIOTRODE
Kholber Corp.
DRX
Jun 19, 1984K840465Q-MED ELECTRODE
Qmed, Inc.
DRX
May 23, 1984K832903ESOPHOGRAL MULTIPROBE
Vital Signs, Inc.
DRX
May 9, 1984K832429CARDIO TRACE ELECTRODE
Poly-Med Splint Co.
DRX
Apr 1, 1984K834445MEDI-TRACE QUIKSET DX DIAG. ELECT-
Graphic Controls Corp.
DRX
Feb 10, 1984K833899TDK ECG ELECTRODE MEL-08
Tdk Corp.
DRX
Jan 27, 1984K833695ADULT MONITORING ELECTOR@@RODE 9431-300
Marquette Electronics, Inc.
DRX
Dec 22, 1983K832877PRE-GELLED DISPOS ELECTRODE
Advance Tech Intl.
DRX
Dec 16, 1983K832516MAGNATRODE CARDIAC MONITORING ELECTRODE
R2 Corp.
DRX
Sep 9, 1983K831977C TEC SERIES 9000 E.C.G. ELECTRODE
Speywood Medical, Ltd.
DRX
Jun 15, 1983K830655QUIK-SILVER RESTING ECG ELECTRODE
Quinton, Inc.
DRX
Jun 3, 1983K830362INFANT ELECTRODE BELT
Sentry Medical Products, Inc.
DRX
Apr 28, 1983K830663PENCIL SKIN ABRADER
Ndm Corp.
DRX
Nov 1, 1982K822750MEDI-TRACE 5' OFFSET ELECTRODE
Graphic Controls Corp.
DRX
Oct 15, 1982K822798DISPOSABLE ELECTRODE #1900
Andover Medical, Inc.
DRX
Jul 30, 1982K821846LDS MONITORING ELECTRODE
Life Design Systems, Inc.
DRX
Jul 30, 1982K821802CENTURION ELECTRODE BELT
Clinical Data, Inc.
DRX
Jul 30, 1982K821434EKG (ECG) ELECTRODES
Dupaco, Inc.
DRX
Jul 8, 1982K821535VITALINE DISPOSABLE EKG ELECTRODE-LEAD
The Halverstadt Co.
DRX
Jul 2, 1982K821757QUIK - PREP2 ELECTRODE
Quinton, Inc.
DRX
Jun 17, 1982K821506MEDICOTEST ECG ELECTRODES
Medicotest, Inc.
DRX
May 25, 1982K821438RED DOT MONITORING ELECTRODES #2260/65
3M Company
DRX
May 18, 1982K821137MEDITRACE PELLET ELECTRODE
Graphic Controls Corp.
DRX
Mar 1, 1982K820122PIONEER II BACK PLATE ELECTRODE
Life Science Instrumentation, Inc.
DRX
Dec 29, 1981K813176GEL ELECTRODE
Dyn-A-Med Products
DRX
Nov 27, 1981K813013GEL ELECTRODE
Arndt Automation & Assoc.
DRX
Nov 2, 1981K812878THE NEW 1600 ELECTRODE
Andover Medical, Inc.
DRX
Sep 25, 1981K812276DISPOSABLE ELECTRODE, #1610
Andover Medical, Inc.
DRX
May 13, 1981K810895ESOPHAGEAL PILL ELECTRODE
Con Med Equipment, Inc.
DRX
Mar 17, 1981K810563QUINTON LTE ELECTRODE
Quinton, Inc.
DRX
Mar 11, 1981K803179DISPOSABLE ELECTRODE FOR EKG
Midwest Monitoring
DRX
Jan 29, 1981K810103ADULT ECG ELECTRODE #60-0724
Aspen Laboratories, Inc.
DRX
Jan 29, 1981K810102INFANT ECG ELECTRODE #60-1029
Aspen Laboratories, Inc.
DRX
Nov 12, 1980K802576EXTERNAL JUGULAR CVP CATHERIZATION KIT
Willson
DRX
Sep 9, 1980K801846ELECTROCARDIOGRAPH ELECTRODE
Phoenix Glove Co.
DRX
May 23, 1980K800935R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)
R2 Corp.
DRX
May 23, 1980K800930R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.
R2 Corp.
DRX
Feb 26, 1980K800201ESOPHAGEAL PILL-ELECTRODE
Arzbaecher & Co.
DRX

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