Panels › Obstetrics/Gynecology › Product code HFM · Class 2
Monitor, Uterine Contraction, External (For Use In Clinic)
Regulation 884.2720
0510(k)s in 12 months (23 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in HFM
| Company | 510(k)s | Recalls |
|---|---|---|
| Pacific Medical Group Inc. | 0 | 8 |
| Aequitron Medical, Inc. | 2 | 0 |
| Corometrics Medical Systems, Inc. | 2 | 0 |
| Tokos Medical Corp. | 2 | 0 |
| Ventrex, Inc. | 2 | 0 |
| Advantage Medical Systems, Inc. | 1 | 0 |
| Air-Shields Vickers, Inc. | 1 | 0 |
| American I.V. Products, Inc. | 1 | 0 |
| Carelink | 1 | 0 |
| Clinical Innovations, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 2014 | K140163 | KOALA TOCO Clinical Innovations, LLC | HFM |
| Jul 12, 2006 | K061044 | FEATHERLITE AQUA TOCODYNAMOMETER Ventrex, Inc. | HFM |
| Sep 14, 2004 | K040392 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING American I.V. Products, Inc. | HFM |
| Jan 17, 2002 | K013477 | TOCO LITE, MODEL TD-01 Ventrex, Inc. | HFM |
| Mar 22, 2000 | K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 Precision Dynamics Corp. | HFM |
| Jan 18, 2000 | K992811 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING Epic Medical Equipment Services, Inc. | HFM |
| May 22, 1996 | K954847 | DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES Ocg Systems, Inc. | HFM |
| Aug 4, 1995 | K952579 | TOCO TRANSDUCER Scientific Device Manufacturer, LLC | HFM |
| May 26, 1993 | K920152 | BUBBLE TOCO Utah Medical Products, Inc. | HFM |
| Mar 29, 1991 | K910282 | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER Graphic Controls Corp. | HFM |
| Feb 19, 1991 | K904691 | AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST Air-Shields Vickers, Inc. | HFM |
| Nov 7, 1990 | K903623 | MODEL600 UTERINE ACTIVITY MONITOR Corometrics Medical Systems, Inc. | HFM |
| Oct 25, 1990 | K902104 | ORION WATCHGUARD Orion Industries | HFM |
| Jan 22, 1990 | K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR Healthdyne, Inc. | HFM |
| Nov 3, 1989 | K893770 | TERM GUARD II DEVICE Tokos Medical Corp. | HFM |
| Jun 8, 1989 | K891997 | CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER Corometrics Medical Systems, Inc. | HFM |
| Mar 1, 1989 | K882080 | MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. Aequitron Medical, Inc. | HFM |
| Mar 11, 1988 | K874631 | HEALTHPHONE TOCO MODEL Carelink | HFM |
| Mar 11, 1988 | K873150 | PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS. Pediatric Diagnostic Service | HFM |
| Jul 9, 1986 | K860933 | AIR-CUSHION TOCOTONOMETER International Biomedics, Inc. | HFM |
| Mar 12, 1986 | K853856 | EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET Aequitron Medical, Inc. | HFM |
| Nov 1, 1984 | K843011 | TERM GUARD 5000 UTERINE ACTIVITY Tokos Medical Corp. | HFM |
| Jun 19, 1984 | K840747 | TOCO DATA TELEPHONE TRANSMITTER DT100P Advantage Medical Systems, Inc. | HFM |
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