Profile: Elmed Inc. specializes in reusable electrosurgical equipment & accessories. We are involved in monopolar electrosurgical technology. Our retract robot is designed to assist surgeons during intensive procedures and to free surgical assistants. Our rod lens laparoscopes represents the latest in technology, in the design and fabrication of rigid endoscopes. All our laparoscopes are hand crafted by optical instrument makers & tested to exact specifications.

The company has revenues of USD 1-5 Million, has ~20 employees.

FDA Registration Number: 1412854

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• Tonsil Snares (FDA Code: KBZ / 874.4420)

• Towel Clip

• Tracheal Hook

• Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ / 882.5890) A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

• Traumatic Grasping Forceps

• Treatment Tables

• Triangle Needle Holder

• Triangle Type Neurological Hammer

• Tungsten Carbide Adson Dressing Forceps

• Tungsten Carbide Needle Holders

• Ultrasonic Diathermy for use in Applying Therapeutic Deep Heat (FDA Code: IMI / 890.5300) An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

• Ultrasonic Fetal Arterial Pressure Monitor (FDA Code: HEQ / 884.2660) A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

• Ultrasonic Transducer (FDA Code: JOP / 870.2880) An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

• Unipolar Endoscopic Coagulator-cutter and Accessories (FDA Code: KNF / 884.4160) A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

• Unipolar Laparoscopic Coagulator (FDA Code: HFG / 884.4160)

• Universal Castroviejo Corneal Scissors

• Urological Table

• Urology Stone Manipulation, Extracorporeal Lithotripsy

• Uterine Biopsy Punch

• Uterine Dressing Forceps

• Uterine Tenaculum (FDA Code: HDC / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Uterine Tenaculum Forceps

• Uterine Tenaculum Hooks

• Utility Forceps

• Vaginal Retractors (FDA Code: HDL / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Valve Grasping Tissue Forceps

• Vascular Needle Holder

• Vascular Tissue Forceps

• Vectorcardiograph (FDA Code: DYC / 870.2400) A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.

• versatile foot Switching

• Vertical Needle Holder

• Vessel Retractor

• Video Equipment Cart

• Wireless Foot Switch

• Xenon Arc Endoscope Light Source (FDA Code: GCT / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.