Panels › Gastroenterology, Urology › Product code FFX · Class 2
System, Gastrointestinal Motility (Electrical)
Regulation 876.1725
2510(k)s in 12 months (70 all time)
2recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in FFX
| Company | 510(k)s | Recalls |
|---|---|---|
| Crospon, Ltd. | 7 | 0 |
| Medtronic Functional Diagnostics A/S | 7 | 0 |
| Sandhill Scientific, Inc. | 6 | 1 |
| Medical Measurement Systems B.V. | 5 | 0 |
| Mui Scientific | 5 | 0 |
| Covidien, LLC | 2 | 1 |
| Diversatek Healthcare | 1 | 2 |
| Sierra Scientific Instruments, Inc. | 2 | 1 |
| Anx Robotica Corp | 2 | 0 |
| Dentsleeve Pty., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 8, 1998 | K980946 | MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP Dentsleeve Pty., Ltd., AU | FFX |
| Sep 23, 1997 | K972439 | ANORECTAL MANOMETRY ANALYSIS MODULE Medtronic-Synectics, SE | FFX |
| Jun 5, 1997 | K963064 | ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM Laborie Medical Tech Corp. | FFX |
| Apr 9, 1996 | K942247 | SMALL BOWEL ANALYSIS SOFTWARE Sandhill Scientific, Inc. | FFX |
| Dec 29, 1994 | K921682 | ZINETICS AMC Zinetics Medical, Inc. | FFX |
| Apr 1, 1994 | K932306 | MICROINFUSOR Sandhill Scientific, Inc. | FFX |
| Dec 23, 1993 | K920664 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION Diagnostic Ultrasound Corp. | FFX |
| Jul 30, 1992 | K921062 | GAELTEC MPR SERIES Medical Measurements, Inc. | FFX |
| Jun 19, 1991 | K905154 | GASTROSCAN Medics Instrument Corp., SE | FFX |
| Jul 27, 1990 | K900058 | WILSON-COOK BILIARY MOTILITY CATHETER Wilson-Cook Medical, Inc. | FFX |
| Aug 11, 1988 | K880581 | AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. Synectics-Dantec | FFX |
| Jul 8, 1988 | K881609 | SITZMARKS Lafayette Pharmacal, Inc. | FFX |
| Feb 8, 1988 | K874690 | GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER Mentor Corp. | FFX |
| Oct 31, 1983 | K832869 | MOTILITY MEASUREMENT SYS MMS-100 Narco Bio-Systems | FFX |
| Jun 2, 1983 | K831347 | MICROCAPILLARY INFUSION SYSTEM J.S. Biomedicals, Inc. | FFX |
| Apr 6, 1983 | K830421 | SYN-02 PN AMPLIFIER Biosearch Medical Products, Inc. | FFX |
| Feb 15, 1983 | K823701 | MOTILITY CATHETERS Mui Scientific, CA | FFX |
| Aug 13, 1981 | K812103 | ESOPHAGEAL MOTILITY APPARATUS Honeywell, Inc. | FFX |
| Jun 13, 1978 | K780812 | ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330 Honeywell, Inc. | FFX |
| Nov 30, 1976 | K760761 | ESOPHAGEAL MOTILITY TUBE Sherwood Medical Industries | FFX |
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