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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260 Open, Classified |
HFM | K012718 |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205 Open, Classified |
HFM | K012718 |
| Sep 11, 2019 | Pacific Medical Group Inc. Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B Open, Classified |
HFM | K012718 |
| Sep 11, 2019 | Pacific Medical Group Inc. Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Open, Classified |
HFM | K012718 |
| Sep 11, 2019 | Pacific Medical Group Inc. Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, Open, Classified |
HFM | K012718 |
| Sep 11, 2019 | Pacific Medical Group Inc. External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH93 Open, Classified |
HFM | K012718 |
| Sep 11, 2019 | Pacific Medical Group Inc. Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Open, Classified |
HFM | K012718 |
| Sep 11, 2019 | Pacific Medical Group Inc. Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometric Open, Classified |
HFM | K012718 |
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