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The ECOM CV4 (Endotracheal Cardiac Output Monitor) System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM Endotracheal Tube. The ECOM CV4 System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used. The ECOM CV4 System will display the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressures.

The ECOM CV4 System consists of an ECOM CV4 Endotracheal Tube and an integrated ECOM CV4 Monitor. The ECOM CV4 Monitor includes a Tube Cable, Arterial Pressure Cable, ECG Cable, ECG Lead Wire, and power cordset. The ECOM CV4 System applies a high frequency, low amplitude electrical current and measures the resulting voltage directly from the tracheal mucosa by way of an ECOM CV4 Endotracheal Tube. The ECOM CV4 Monitor will display the tube and surface R-Wave and the Impedance Waveforms as well as the patient's Caridac Output (CO), Heart Rate (HR), Stroke Volume (SV), Systolic and Diastolic Pressures.

The IM2001 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment. For prescription use only.

The IM-2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate based on the principal of Reflection. The device consists of a small and light-weight sensor and is intended to monitor arterial SaO2 from the forehead. IM2001 Pulse Oximeter consists of a sensor that emits and detects red and infrared light, a holder, a connecting cable, and a microprocessorcontrolled monitoring console Signal Processing Unit (monitor). The monitor displays digital values of Sp02 and Pulse Rate. The IM2001 is intended for prescription use with adult and pediatric patients in hospitals. hospital-type facilities, and intra-hospital transport environments.

Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment for residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

The Imagen isoSTARTM I-125 Interstitial Seed, Model IS-12501 uses 131 spheres encapsulated in a titanium tube.

The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation.

Imagyn's Optical Aspirating Curette consists of a disposable aspirating curette intended to remove tissue from the uterus and from the mucosal lining of the uterus by scraping and aspirating. The curette has a multi-lumen design that accommodates the introduction of Imagyn's reusable fiberoptic hysteroscope, which allows for visualization of the uterine cavity during the curettage procedure.

This device is intended for the treatment or management of erectile dysfunction/impotence.

The Imagyn Medical Technologies, Inc.'s Impower System vacuum erection device ("Impower") consists of a vacuum pump, tension rings, seal rings, clear plastic cylinder, and a tube of personal lubricant.

These devices are intended for the treatment or management of erectile dysfunction/impotence.

The Imagyn Medical Technologies, Inc. ErecAid System Classic vacuum erection system ("ErecAid") consists of a vacuum pump, tension rings, insert ring, clear plastic cylinder, and a tube of personal lubricant. The StayErec Tension Ring consists of a ring of the same material, and used in the same manner as the predicate device.