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
Jan 28, 1988K874423PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
Hewlett-Packard Co.
DRX
Jan 28, 1988K874422PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D
Hewlett-Packard Co.
DRX
Jan 28, 1988K874421PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
Hewlett-Packard Co.
DRX
Jan 28, 1988K872866STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)
Labeltape Meditect, Inc.
DRX
Dec 30, 1987K874437TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE)
Labeltape Meditect, Inc.
DRX
Dec 29, 1987K873682FERRIS ECG ELECTRODE W/HYDROGEL
Ferris Mfg. Corp.
DRX
Dec 7, 1987K874628RESUBMITTED STANDARD MICROPORE ECG ELECTRODE
Labeltape Meditect, Inc.
DRX
Nov 23, 1987K873442ECG ELECTRODE SYSTEM
Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S
DRX
Oct 16, 1987K872871NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)
Labeltape Meditect, Inc.
DRX
Oct 9, 1987K872784MACTRODE-II
Marquette Electronics, Inc.
DRX
Aug 3, 1987K871441ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE
Nitto Denko America, Inc.
DRX
Jun 10, 1987K871748THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE
The Buddy Systems, Inc.
DRX
Jun 10, 1987K871668BIODAN TYPE COMET ELECTRODE
National Medical Technology, CA
DRX
Jun 8, 1987K871325BOWEN REUSEABLE/DISPOSABLE ELECTRODE
Bowen & Company, Inc.
DRX
Jun 5, 1987K871626ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200
Jason Marketing Co.
DRX
May 12, 1987K871412CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO
Contour Electrodes, Inc.
DRX
May 11, 1987K864260APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)
Grandcor Medical Systems
DRX
May 6, 1987K864690ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD
Multi Biosensors, Inc.
DRX
Apr 10, 1987K870873MD MONITORING/DIAGNOSTIC ELECTRODE
Lectec Corp.
DRX
Mar 23, 1987K870834TDK ECG ELECTRODE MEL-10
Tdk Corp., JP
DRX
Mar 13, 1987K865011PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER
Labeltape Meditect, Inc.
DRX
Mar 13, 1987K864586S&W ELECTRODE TYPES 888, 844, 988 AND 944
S & W Medico Teknik
DRX
Mar 11, 1987K863674TRACETS 2000/ELECTRODES
Lectec Corp.
DRX
Feb 10, 1987K864722MEDI-TRACE INFANT ELECTRODE
Graphic Controls Corp.
DRX
Jan 14, 1987K864868MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
Hewlett-Packard Co.
DRX
Jan 6, 1987K863904DISPOSABLE ECG MONITORING ELECTRODE
Clinical Data, Inc.
DRX
Jan 6, 1987K863369MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES
Tdk Corp.
DRX
Dec 8, 1986K863584EM II STRESS TEST ELECTRODE
Electromed Intl., Ltd.
DRX
Dec 8, 1986K863540EM II DISPOSABLE ELECTRODE
Electromed Intl., Ltd.
DRX
Nov 21, 1986K863366PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE
Labeltape Meditect, Inc.
DRX
Nov 20, 1986K863845EM III DISPOSABLE ELECTRODE
Electromed Intl., Ltd.
DRX
Sep 15, 1986K862618SKINTACT AG ELECTRODES
Leon H. Lang Co., AT
DRX
Aug 6, 1986K862765EUROMED S-601
Lectec Corp.
DRX
Aug 6, 1986K862746EM DIAGNOSTIC ECG ELECTRODE
Electromed Intl., Ltd.
DRX
Aug 6, 1986K862655SIGNA II RESTING ECG ELECTRODE
Kone Instruments, Inc.
DRX
Aug 6, 1986K861246PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
Conmedcorp
DRX
Aug 6, 1986K861099GEREONICS BIOPOTENTIAL SKIN ELECTRODES
Gereonics, Inc.
DRX
Jul 1, 1986K861158S&W TYPE 888 ELECTRODE
National Medical Technology
DRX
May 8, 1986K860827EM STRESS ELECTRODE
Electromed Intl., Ltd.
DRX
May 8, 1986K854433ECG MONITORING/DEFIBRILLATION ELECTRODE
Andover Medical, Inc.
DRX
Apr 23, 1986K8547575000 SERIES ECG ELECTRODES
Alternative Design Systems, Inc.
DRX
Apr 17, 1986K853774EM ELECTRODE
Electromed Intl., Ltd.
DRX
Apr 11, 1986K853939ECG-ELECTRODE(SWAROMED)
D. Swarovski & Co., AT
DRX
Feb 28, 1986K853993DOBE (MODIFIED)
Phoenix Medical Technology, Inc.
DRX
Jan 13, 1986K853705BOMED-EEA
Bomed Medical Mfr., Ltd.
DRX
Jan 7, 1986K853038DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
Bio-Detek, Inc.
DRX
Oct 24, 1985K851522DIAGNOSTIC ECG DISPOSABLE ELECTRODE
Sentry Medical Products, Inc.
DRX
Sep 16, 1985K852469SAF-D-FIB
Medtronic Andover Medical, Inc.
DRX
Sep 16, 1985K851732CARBOCONE
Imtech Corp.
DRX
Aug 9, 1985K852177FOAM ECG ELECTRODES
Clinical Data, Inc.
DRX

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