Profile: Karl Storz GmbH & Co. KG specializes in the production and sale of medical instruments & devices. We offer a range of endoscopic equipment for human & veterinary medicine and for industrial applications. The instruments developed by us permit a whole range of endoscopic, minimally invasive operations, such as support immersion endoscopy, cavity endoscopy, endoscopic treatment of disorders of the salivary duct, arthroscopy of the temperomandibular joint and endoscopically assisted procedures for treating comminuted fractures of the zygomatic arch, the zygomatic process and the condylar process. Our otorhinolaryngology branch of medicine comprises rigid endoscopes spanning the entire spectrum of lengths, diameters and directions of view, flexible fiberscopes & close on 6,000 different instruments. We also offer an extensive product range for skull base surgery, pituitary gland surgery and otoneurosurgery, which includes a large number of flexible & rigid endoscopes as well as instruments for advanced operating techniques in this field. From basic equipment for the ENT practice through complete sets of endoscopic and surgical instruments up to the high-technology system for video-assisted endoscopy & autofluorescence, we provide an entire range of endoscopes & instruments.

The company has ~2000 employees and is ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE certified.

FDA Registration Number: 9614434
US Agent: Susie S. Chen / Karl Storz Endoscopy-america, Inc.
Phone: +1-(424)-218-8201  Fax: +1-(424)-218-8519  E-Mail:

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• Tonsillectome (FDA Code: KCA / 874.4420)

• Total Ossicular Replacement Prosthesis (FDA Code: ETA / 874.3495) A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.

• Tracheal Tube with/without Connector (FDA Code: BTR / 868.5730) A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

• Tracheostomy Cannula

• Tracheotomy Kit

• Transabdominal Amnioscope and Accessories (FDA Code: HFA / 884.1600) A transabdominal amnioscope is a device designed to permit direct visual examination of the fetus by a telescopic system via abdominal entry. The device is used to ascertain fetal abnormalities, to obtain fetal blood samples, or to obtain fetal tissue. This generic type of device may include the following accessories: trocar and cannula, instruments used through an operating channel or through a separate cannula associated with the amnioscope, light source and cables, and component parts.

• Transcervical Endoscope & Accessories (FDA Code: HEZ / 884.1660) A transcervical endoscope is a device designed to permit direct viewing of the fetus and amniotic sac by means of an open tube introduced into the uterus through the cervix. The device may be used to visualize the fetus or amniotic fluid and to sample fetal blood or amniotic fluid. This generic type of device may include obturators, instruments used through an operating channel, light sources and cables, and component parts.

• Triangle Needle Holder

• Trocars

• Tubing And Tubing/Filter Fits (FDA Code: NVT / 884.1700) A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

• Tungsten Carbide Needle Holders

• Ultrasonic Lithotriptor (FDA Code: FEO / 876.4480)

• 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.

• Ureteral Catheter Dilator (FDA Code: EZN / 876.5470) A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

• Ureteroscopic Biopsy Forceps

• Ureterotome

• Urethral Dilators (FDA Code: KOE / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

• Urethroscope (FDA Code: FGC / 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.

• Urethrotome (FDA Code: EZO / 876.4770) A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.

• Urological Bougie (FDA Code: FAX / 876.5520)

• Urological Extracorporeal Shock-wave Lithotriptor (FDA Code: LNS / 876.5990) An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.

• Urological Irrigation System (FDA Code: LJH / 876.5130)

• Used Cystoscopes

• Uterine Biopsy Forceps

• Uterine Biopsy Punch

• Uterine Curettes (FDA Code: HCY / 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 Manipulator Injector & Accessories

• Uterine Tenaculum (FDA Code: HDC / 884.4530)

• Uterine Tenaculum Forceps

• Uterine Tenaculum Hooks

• Uterotubal Carbon-Dioxide Insufflator and Accessories (FDA Code: HES / 884.1300) A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.

• Vaginal Dilators (FDA Code: HDX / 884.3900) A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.

• Vaginoscope

• Vaginoscope And Accessories (FDA Code: MOK / 884.1630) A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

• Vascular Clamps (FDA Code: DXC / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

• Vascular Needle Holder

• Ventilating Rigid Bronchoscope

• Vertical Needle Holder

• Video Equipment Cart

• Video Image Printer

• Videotape/Videodisc Recorder

• Withdrawal/Infusion Pump (FDA Code: DQI / 870.1800) A withdrawal-infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samples for use in determining cardiac output.

• Xenon Arc Endoscope Light Source (FDA Code: GCT / 876.1500)

• Y Piece Breathing Circuit (FDA Code: CAI / 868.5240) An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

• Y-Stent Forceps