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 17, 2000K0006903M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
Minnesota Mining and Mfg. Co.
DRX
Apr 13, 2000K000206PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
Axelgaard Mfg. Co., Ltd.
DRX
Dec 6, 1999K990115DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
Maersk Medical A/S
DRX
Dec 6, 1999K990113DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
Maersk Medical A/S
DRX
Dec 6, 1999K990112DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
Maersk Medical A/S
DRX
Dec 6, 1999K990111DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
Maersk Medical A/S
DRX
Dec 6, 1999K990110DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
Maersk Medical A/S
DRX
Nov 26, 1999K991105ECG ELECTRODE (VARIOUS)
Conmedcorp
DRX
Oct 26, 1999K982521SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
Leonhard Lang Co., AT
DRX
Jan 15, 1999K983689BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
Medicotest A/S
DRX
Nov 13, 1998K981964MEDI-TRACE 4103 NEONATAL ELECTRODE
Graphic Controls Corp.
DRX
Oct 14, 1998K982470ECG ELECTRODES APRON
Tapuz Medical Technology , Ltd., IL
DRX
Jul 26, 1998K9744453M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
3M Healthcare
DRX
Feb 10, 1998K973663PALJET-B
Golden Gate Bio-Device
DRX
Dec 19, 1997K973727ELECTRODE, ELECTROCARDIOGRAPH
Don Tay Industries
DRX
Jul 8, 1997K972001NICAS(TM) ELECTRODE
Ni Medical
DRX
Jun 11, 1997K9714443M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
3M Medical Products Group
DRX
Apr 15, 1997K970755STEALTHSHIELD
Vital Connections, Inc.
DRX
Apr 9, 1997K9707963M RED DOT 2560 & 2570 MONITORING ELECTRODES
3M Healthcare
DRX
Mar 11, 1997K963787EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
Conmedcorp
DRX
Mar 4, 1997K970125NOAH MONITORING ELECTRODE SYSTEM
Contour Medical Technology, Inc.
DRX
Jan 7, 1997K963975VERSATEC 310 ELECTRODE
Versatec, Inc.
DRX
Dec 11, 1996K963159CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
Cmc Sense-It, Inc.
DRX
Dec 9, 1996K961643MEDICOTEST ECG ELECTRODES
Medicotest, Inc.
DRX
Nov 25, 1996K964213TRACE RITE SOLID GEL ECG ELECTRODES
Bio-Detek, Inc.
DRX
Nov 19, 1996K963151MEDI-TRACE 5700 RESTING ECG ELECTRODE
Graphic Controls Corp.
DRX
Nov 15, 1996K963038MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
Graphic Controls Corp.
DRX
Oct 28, 1996K960968MEDI-TRACE 200, MEDI-TRACE 200-30
Graphic Controls Corp.
DRX
Aug 29, 1996K962115CAMBRIDGE HEART HI-RES ECG ELECTRODE
Cambridge Heart, Inc.
DRX
Aug 8, 1996K961288BODYTRODE
Marquette Electronics, Inc.
DRX
Jul 24, 1996K962122SENTRY RADIOTRANSLUCENT ECG ELECTRODES
Sentry Medical Products, Inc.
DRX
Jul 23, 1996K955815G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE
Cmc Sense-It, Inc.
DRX
Jul 18, 1996K960721PACEART WRIST ELECTRODES
Paceart, Inc.
DRX
Jul 11, 1996K954773QUICKELS QS 100 SYSTEM
Ferguson Medical
DRX
Jul 11, 1996K954772QUICKELS QS 200 SYSTEM
Ferguson Medical
DRX
Jun 21, 1996K953649DISPOSABLE ECG ELECTRODE
Kendall-Ltp
DRX
Jun 7, 1996K961395MEDI-TRACE RADIOLUCENT
Graphic Controls Corp.
DRX
May 17, 1996K955800SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE
Cmc Sense-It, Inc.
DRX
May 17, 1996K944497UNILECT, MONITAB AND BIOTRACE-HR
Msb , Ltd., GB
DRX
May 16, 1996K954389CONMED ECG/EKG ELECTRODES
Conmedcorp
DRX
May 16, 1996K944496BIOTRACE-N, NS, 410 AND RT
Msb , Ltd., GB
DRX
Apr 9, 1996K960264CONMED EKG STRIPPER
Conmedcorp
DRX
Feb 6, 1996K954388CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
Conmedcorp
DRX
Dec 12, 1995K950473DISPOSABLE ECG MONITORING ELECTRODE
Nikomed U.S.A., Inc.
DRX
Nov 14, 1995K950475DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
Nikomed U.S.A., Inc.
DRX
Nov 14, 1995K950472DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
Nikomed U.S.A., Inc.
DRX
Nov 6, 1995K950480DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM
Nikomed U.S.A., Inc.
DRX
Nov 6, 1995K950478DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM
Nikomed U.S.A., Inc.
DRX
Nov 6, 1995K950477DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
Nikomed U.S.A., Inc.
DRX
Nov 6, 1995K950474DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM
Nikomed U.S.A., Inc.
DRX

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