(FDA Code:
GXX /
882.1925)
Identification. An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.
Sonomed, Inc.,
Diagnostic Sonar Ltd.
Valleylab,
Medela, Inc,
Jedmed Instrument Company,
more...
Ultrasound is a cyclic sound pressure with a frequency greater than the upper limit of human hearing, this limit being approximately 20 kilohertz (20,000 hertz). It is useful in the detection of pelvic abnormalities and can involve techniques known as abdominal (transabdominal) ultrasound, vaginal (transvaginal or endovaginal) ultrasound in women, and also rectal (transrectal) ultrasound in men.
Whittemore Enterprises, Inc.,
KPI Ultrasound,
Envision Medical Sales,
more...
Uni-tab electrodes are designed specially for clinical applications to promote hygienic treatment. It is self-adhering and conformable with thin and flexible low-profile design.
Cadwell Laboratories, Inc.
Universal biomedical amplifier is the ideal product for a wide variety of biomedical applications. Its unique design offers DC-coupled signal transduction and complete electrical isolation without introducing artifacts common to most biomedical recording systems: baseline drift, amplifier noise, power line interference, distortion, and prolonged amplifier saturation.
LKC Technologies, Inc.
Cadwell Laboratories, Inc.
Siemens Healthcare Diagnostics
Chicago Biomedical Services Company,
Hologic Inc,
Integra Radionics, Inc.,
more...
Vagus nerve stimulation system is used to control epileptic seizures. It uses a surgically implanted medical device that delivers electrical pulsed signals to the vagus nerve in the left side of the neck. It is effective in significantly reducing the number and/or intensity of seizures in many people suffering from epilepsy and has the potential for use in the treatment of other inadequately treated, chronic disorders.
Cyberonics Incorporated,
Fort Wayne Metals,
Universal Medical Systems, Inc
Siemens Healthcare Diagnostics
(FDA Code:
NHC /
882.41)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.
Classification. Class II (performance standards).
Medtronic Xomed Surgical Products, Inc,
Cook Group Incorporated,
I-Flow Corporation,
more...
(FDA Code:
HCD /
882.406)
Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.
Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9.
Vyaire Medical, Inc.,
Luxtec,
Integra LifeSciences Corporation,
more...
(FDA Code:
HCA /
882.41)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.
Classification. Class II (performance standards).
Medtronic Xomed Surgical Products, Inc,
Sophysa USA, Inc.,
Codman & Shurtleff, Inc.,
more...
Millennium Surgical Corp.,
Creaspine
Vertebroplasty is an image-guided treatment for the alleviation of back pain from vertebral compression fracture. It can provide pain relief and prevent further collapse of fractures that do not heal naturally. It stabilizes the fracture and helps to prevent further collapse of the vertebral body.
Kyphon, Inc.,
Biomet, Inc,
Bio-medical Devices Intl (BMDI),
more...
Vertical needle holder holds low dose rate brach therapy needles in place for loading. It provides stainless steel shielding for loaded needles. The vertical needle holder is also available as a component in the needle loading platform and shield with vertical needle holder system. Needle tips are not in danger of blunting as needles are suspended in the needle holder.
Marina Medical Instruments Inc.,
Elmed Inc.,
Akorn, Inc.,
more...
(FDA Code:
LLN /
882.12)
WR Medical Electronics Co.,
Vision Sciences, Inc.,
Neuro-Diagnostic Assoc.,
more...
Hologic Inc,
Integra Radionics, Inc.
Virtual fluoroscopy system is a medical device called a fluoroscope thats takes an X-ray of a patient and displays it on a viewing screen, much like a TV. It is a navigational system that combines a conventional C-arm fluoroscope with a surgical computer. By harnessing the power of the computer with the fluoroscope, allows the surgeon to see many views of the spine from many different angles simultaneously, all with minimal X-ray exposure.
Hologic Inc
Oasis Medical, Inc.,
Grass Technologies,
Universal Medical Systems, Inc,
more...
Cyberonics Incorporated
Watchmaker forceps have finer tips than regular tweezers. These forceps are mainly associated with biological applications. These are intended for the most demanding work, especially when a microscope is required. The curved forceps are ideal for tweezing out in grown hairs or fine metal shards.
Mccoy Health Science Supply,
Hamilton Bell Co. Inc.,
Indigor Instruments
Advanced Bionics Corporation,
Magstim Company US LLC,
Grass Technologies,
more...
Covidien,
Northern Digital Inc.
Shahrud International,
Kaisers Surgical Instruments Pty Ltd
Diversified Diagnostic Products, Inc.
Kroslak Enterprises, Inc.,
Aesculap Inc.,
Medicon eG,
more...