Profile: E-Z-EM Inc manufactures products used for imaging the gastrointestinal tract. Our product ranges from a disposable barium enema administration kit to advanced CT and virtual colonoscopy products. Our product line includes injectable contrast agents, oral contrast agents, virtual colonoscopy, fluoroscopy, endoscopy, mouth pieces, mammography & ultrasound, ultrasound needles, MRI needles, CT biopsy needles, Stat sensors, and bone biopsy needles. We develop imaging solutions that render superior methodology, procedural simplicity and added convenience for physicians & their patients. Our varibar is a videofluoroscopic examination of the swallowing process performed to help diagnose dysphagia.

The company was founded in 1962. NASDAQ:EZEM (SEC Filings)

FDA Registration Number: 2411512

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• 3D Imaging Devices

• Amniotic Fluid Sampler (FDA Code: HIO / 884.1550) The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.

• Angiography Equipment & Systems Accessories

• Automatic Carbon-Dioxide Insufflator (FDA Code: FCX / 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.

• Barium Enema with Bag Retention Catheter (FDA Code: FGD / 876.5980) A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

• Biomedical Devices

• Biopsy Supplies

• Biopsy Tray without Biopsy Instruments (FDA Code: FCH / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Breathing Mouthpiece (FDA Code: BYP / 868.5620) A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

• Cardiovascular Biopsy Needle (FDA Code: DWO / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Cardiovascular Trocar (FDA Code: DRC / 870.1390) A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

• Computed Tomography

• Computed Tomography Accessories

• Contract Manufacturers

• Contrast Injectors & Media

• Contrast Injectors Accessories

• Contrast Media

• Diagnostic Aids

• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

• Disposable Barium Enema Kit (FDA Code: FCD / 876.5210)

• Disposable Needles

• Education & Training

• Electroconductive Media (FDA Code: GYB / 882.1275) Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

• Endoscope Accessories (FDA Code: KOG)

• Enema Supplies

• Film Holders & Accessories

• Forceps Needle Holders

• Gastro-Intestinals

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730)

• General & Plastic Surgery Eustachian Catheter (FDA Code: GBY / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• General Diagnostic Supplies

• General Hypodermic Supplies

• General Medical Supplies

• General Surgery Supplies

• General Urology Supplies

• Graduated Liquid Medication Container (FDA Code: KYW / 880.6430) A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.

• Infusion Catheter (FDA Code: JCY / 878.4200)

• Injectable Contrast Media

• Iodinated Contrast Media

• IV Sets

• Liquid Crystal Thermographic System (FDA Code: LHM / 884.2982) A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use as an adjunct to physical palpation or mammography in diagnostic screening for detection of breast cancer or other uses is a nonelectrically powered or an AC-powered device applied to the skin that displays the color patterns of heat sensitive cholesteric liquid crystals that respond to temperature variations of the surface of the body. This generic type of device may include patient and equipment supports, a means to ensure thermal contact between the patient's skin and the liquid crystals, component parts, and accessories.

• Low Osmolar Contrast Media

• Magnifying Spectacle (FDA Code: HOI / 886.5840) Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.

• Mammography Accessories

• Medical Imaging

• Medical Imaging Kits

• Miscellaneous Injectables

• Monitors Accessories

• MRI Contrast Media