Home › Device types › HFM
Monitor, Uterine Contraction, External (For Use In Clinic)
FDA product code HFM · Class 2 · Obstetrics/Gynecology
33
Registered devices
40
Adverse events
8
Recalls
23
510(k) clearances
Devices with this code
TOCO TRANSDUCER — WIPRO GE HEALTHCARE PRIVATE LIMITEDFEATHERLITE TOCO — PARKER-HANNIFIN CORPORATIONAvalon Ultrasound Transducer — Philips Medizin Systeme Böblingen GmbHAvalon Toco+ MP Transducer — Philips Medizin Systeme Böblingen GmbHFEATHERLITE AQUA — PARKER-HANNIFIN CORPORATIONAvalon ECG/IUP Transducer — Philips Medizin Systeme Böblingen GmbHFEATHERLITE TOCO PLUS — PARKER-HANNIFIN CORPORATIONN/A — WIPRO GE HEALTHCARE PRIVATE LIMITEDN/A — WIPRO GE HEALTHCARE PRIVATE LIMITEDFEATHERLITE TOCO PLUS — PARKER-HANNIFIN CORPORATIONFEATHERLITE TOCO — PARKER-HANNIFIN CORPORATIONKoala Toco® — CLINICAL INNOVATIONS, LLCAvalon TOCO+ Transducer — Philips Medizin Systeme Böblingen GmbHAvalon Fetal & Maternal Patch — Philips Medical Systems HsgAvalon Toco+ Transducer — Philips Medizin Systeme Böblingen GmbHAIV — AMERICAN IV PRODUCTS, INC.FEATHERLITE TOCO PLUS — PARKER-HANNIFIN CORPORATIONAvalon TOCO MP Transducer — Philips Medizin Systeme Böblingen GmbHFEATHERLITE TOCO — PARKER-HANNIFIN CORPORATIONAIV — AMERICAN IV PRODUCTS, INC.N/A — WIPRO GE HEALTHCARE PRIVATE LIMITEDAvalon CL Fetal & Maternal Pod — Philips Medizin Systeme Böblingen GmbHNA — WIPRO GE HEALTHCARE PRIVATE LIMITEDFEATHERLITE TOCO — PARKER-HANNIFIN CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-19 | Pacific Medical Group Inc. | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
| 2019-09-19 | Pacific Medical Group Inc. | Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and |
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. |
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. |
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. |
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. |
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. |
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. |
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