Panels › Gastroenterology, Urology › Product code FFT · Class 1
Electrode, Ph, Stomach
Regulation 876.1400
0510(k)s in 12 months (49 all time)
1recalls in 12 months (11 all time)
8recalls that name a 510(k)
Top companies in FFT
| Company | 510(k)s | Recalls |
|---|---|---|
| Synectics-Dantec | 10 | 0 |
| Sandhill Scientific, Inc. | 4 | 2 |
| Covidien LLC | 0 | 4 |
| Diamond Medical, Inc. | 4 | 0 |
| Given Imaging , Ltd. | 1 | 2 |
| Tonometrics, Inc. | 3 | 0 |
| Biosearch Medical Products, Inc. | 2 | 0 |
| Chemfet Corp. | 2 | 0 |
| Medtronic Gastroenterology / Urology | 0 | 2 |
| Oakfield Instruments, Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 1, 2010 | K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES Given Imaging , Ltd., IL | FFT |
| Feb 28, 2002 | K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE Sandhill Scientific, Inc. | FFT |
| Sep 29, 2000 | K002028 | BRAVO PH MONITORING SYSTEM Endonetics, Inc. | FFT |
| Jan 29, 1997 | K961346 | PH ANALYSIS MODULE Synectics-Dantec, SE | FFT |
| Feb 6, 1996 | K950087 | LOT 440 Medical Instruments Corporation Mic AG, CH | FFT |
| Jan 30, 1996 | K955018 | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR Instrumentarium Corp. | FFT |
| Jun 13, 1995 | K945069 | FLEXILOG 2000 Oakfield Instruments, Ltd., GB | FFT |
| Mar 17, 1995 | K920849 | TRIP CIC CATHETER Tonometrics, Inc. | FFT |
| Jan 24, 1995 | K934434 | CYBERRX MODEL 7200 Cybermed Control Systems, Inc. | FFT |
| Sep 30, 1994 | K925405 | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. Synectics-Dantec | FFT |
| Sep 28, 1994 | K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE Sandhill Scientific, Inc. | FFT |
| Jun 11, 1992 | K913817 | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION Synectics-Dantec, SE | FFT |
| Apr 28, 1992 | K914624 | PH METER, MODIFICATION Synectics-Dantec, SE | FFT |
| Feb 7, 1992 | K912772 | SUPERLOGGER Sandhill Scientific, Inc. | FFT |
| Dec 27, 1991 | K913387 | DIGITRAPPER MARK III Synectics-Dantec, SE | FFT |
| Jul 23, 1991 | K911825 | TRIP(TM) NASOGASTRIC SUMP CATHETER Tonometrics, Inc. | FFT |
| May 17, 1991 | K910694 | ZINETICS INTERNAL REFERENCE PROBE Zinetics Medical, Inc. | FFT |
| Nov 5, 1990 | K903646 | GASTROGRAPH Medics Instrument Corp., DE | FFT |
| Jun 8, 1990 | K902366 | MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT Synectics-Dantec | FFT |
| May 4, 1990 | K896288 | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM Oakfield Instruments, Ltd., GB | FFT |
| Oct 4, 1989 | K883960 | GIPHY MONITOR Vascular Technology Incorporated | FFT |
| Jun 23, 1989 | K891410 | NASOGASTRIC PH SUCTION CATHETER, ST-5001 Sensatronix Medical Systems, Inc. | FFT |
| Oct 12, 1988 | K883234 | TONOMITOR (TM) + SUMP Tonometrics, Inc. | FFT |
| Jul 12, 1988 | K881706 | PROXIMA 1 PH MONITOR Technomanagement, Inc. C/O C.G. | FFT |
| Feb 8, 1988 | K874710 | DIAMOND MEDICAL, INC. MODEL DM 600 Diamond Medical, Inc. | FFT |
| Feb 8, 1988 | K874709 | DIAMOND MEDICAL, INC. MODEL DM 800 Diamond Medical, Inc. | FFT |
| Feb 5, 1988 | K875369 | MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT Diamond Medical, Inc. | FFT |
| Oct 20, 1987 | K871922 | PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA. Chemfet Corp. | FFT |
| Oct 20, 1987 | K871921 | GENERAL PURPOSE COMBINATION PH ELECTRODE Chemfet Corp. | FFT |
| Aug 10, 1987 | K872929 | PH MONITORING SYSTEM Sensatronix Medical Systems, Inc. | FFT |
| Jun 10, 1987 | K871282 | SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE Synectics-Dantec | FFT |
| Apr 10, 1987 | K870606 | TONOMITOR(TM) Tonometrics Holdings SA C/O Mackeen Consultants | FFT |
| Mar 17, 1987 | K863298 | DIAMOND MEDICAL, INC., MODEL DM 700 Diamond Medical, Inc. | FFT |
| Nov 19, 1986 | K862727 | ZINETICS GASTROMETER (TM) Zinetics Medical Technology Corp. | FFT |
| Oct 20, 1986 | K862929 | SYNECTICS MOTILITY SYSTEM Synectics-Dantec | FFT |
| Sep 12, 1986 | K862536 | MODEL 1010 AMBULATORY PH MONITORING SYSTEM Oxford Medilog, Inc. | FFT |
| Feb 24, 1986 | K854514 | AMBI-24 PH/PRESSURE MONITOR Biosearch Medical Products, Inc. | FFT |
| Dec 2, 1985 | K853280 | FOUR CHANNEL PH PROBE Akron City Hospital | FFT |
| Nov 18, 1985 | K853648 | SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO Synectics-Dantec | FFT |
| Jul 25, 1985 | K852289 | MODEL SA3 ESOPHAGEAL PH ELECTRODE World Precision Instruments, Inc. | FFT |
| Jun 13, 1985 | K850778 | SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE Settler Medical Electronics, Inc., CA | FFT |
| May 1, 1985 | K850361 | SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E Synectics-Dantec | FFT |
| Feb 14, 1985 | K850074 | ESOPHOGEAL PH CATHETER Biosearch Medical Products, Inc. | FFT |
| Nov 8, 1984 | K842690 | SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT Synectics AB, SE | FFT |
| Jul 19, 1984 | K841384 | PROXIMA 1 PH MONITOR American Endoscopy, Inc. | FFT |
| Feb 21, 1984 | K834512 | SANDMILL RMS Sandhill Scientific, Inc. | FFT |
| Oct 22, 1982 | K822815 | MODEL 700 GASTROREFLUX MONITOR/AMALYZER Del Mar Avionics | FFT |
| Mar 23, 1982 | K820566 | PATIENT ISOLATOR #S-10/D-10 Microelectrodes, Inc. | FFT |
| Aug 13, 1981 | K811083 | ESOPHAGEAL MOTILITY PROBE Konigsberg Instruments, Inc. | FFT |
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