Panels › Gastroenterology, Urology › Product code EXY · Class 2
Uroflowmeter
Regulation 876.1800
0510(k)s in 12 months (16 all time)
1recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in EXY
| Company | 510(k)s | Recalls |
|---|---|---|
| Life-Tech Intl., Inc. | 3 | 0 |
| Albyn Medical , Ltd. | 1 | 0 |
| Be Technologies, Inc. | 1 | 0 |
| Biodan Medical Systems, Ltd. | 1 | 0 |
| Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) | 0 | 1 |
| Dantec Medical, Inc. | 1 | 0 |
| Diagnostic Ultrasound Corp. | 1 | 0 |
| Emano Metrics, Inc. | 0 | 1 |
| Eutectic Electronics, Inc. | 1 | 0 |
| Fiberoptic Sensor Technlogies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 2014 | K142425 | Uroflowmeter Be Technologies, Inc. | EXY |
| Aug 26, 2003 | K022721 | UROPOWER W.O.M. World of Medicine AG | EXY |
| Sep 19, 1997 | K971913 | GR100F URINE FLOWMETER Albyn Medical , Ltd., GB | EXY |
| Nov 21, 1995 | K953999 | DANTEC DA CAPO Dantec Medical, Inc. | EXY |
| Aug 24, 1995 | K951442 | FLOLAB Synectics Medical, Inc., SE | EXY |
| Mar 8, 1995 | K944972 | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY Myo/Kinetic Systems, Inc. | EXY |
| Feb 9, 1995 | K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION Fiberoptic Sensor Technlogies, Inc. | EXY |
| May 10, 1994 | K941105 | UORCAP,MODEL NUMBER UDS-UCAP Laborie Medical Tech, Inc., CA | EXY |
| Dec 28, 1990 | K904557 | MICROFLO Life-Tech Intl., Inc. | EXY |
| Aug 10, 1990 | K902408 | DIAGNOSTIC ULTRASOUND UFS 1005 Diagnostic Ultrasound Corp. | EXY |
| Jun 8, 1990 | K900770 | HOME URODATA SYSTEM(TM) Biodan Medical Systems, Ltd., IL | EXY |
| Nov 8, 1989 | K894968 | ULTRACOMPACT Eutectic Electronics, Inc. | EXY |
| Jun 17, 1988 | K880504 | MCT MEDICAL BROWNE UROSCAN URODYNAMIC Mct Medical, Inc. | EXY |
| Jan 27, 1988 | K873695 | MODEL 1859 TUMI/PRESSURE MODULE Life-Tech Intl., Inc. | EXY |
| Aug 27, 1987 | K872077 | MODEL 1858 CAVRO/PRESSURE MODULE Life-Tech Intl., Inc. | EXY |
| Jun 3, 1977 | K770897 | URODYNAMIC INSTRUMENTS Life-Tech Instruments, Inc. | EXY |
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