Profile: Richard Wolf GmbH develops endoscopes and modular system solutions for all medical fields. We are accredited with ISO9001 and ISO 13485 certification. Our nephroscopy is used to removal of kidney stones.

The company has ~20 employees.

FDA Registration Number: 9611102
US Agent: Mike Loiterman / Richard Wolf Medical Instruments Corp.
Phone: +1-(847)-913-1113  Fax: +1-(847)-913-0924  E-Mail:

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• Abdominal Flexible Retractor System

• AC-Powered Endoscope and Accessories (FDA Code: GCP / 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.

• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX / 878.4780) A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

• AC-Powered Surgical Instrument Motor (FDA Code: GEY / 878.4820)

• Active Electrosurgical Electrode (FDA Code: FAS / 876.4300) An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• Anoscope and Accessories (FDA Code: FER / 876.1500)

• Anti-Regurgitation Valve with Blood Tubing Set (FDA Code: FJK / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

• Arthroscopes (FDA Code: HRX / 888.1100) An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

• Arthroscopic Accessories (FDA Code: NBH / 888.1100)

• Autoclavable Arthroscopes

• Autoclavable Small Joint Arthroscopes

• Automatic Stabilization and Steering

• Bone Rasps (FDA Code: HTR / 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.

• Bronchoscope Accessories (FDA Code: KTI / 874.4680) A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

• Cables (FDA Code: ISN / 890.3420) An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

• Cameras

• Cameras

• Cameras

• Clip Surgical Applier (FDA Code: GDO / 878.4800)

• Contraceptive Tubal Occlusion Device (FDA Code: KNH / 884.5380) A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.

• Cranioplasty Material Forming Instrument (FDA Code: HBX / 882.4500) A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials.

• Culdoscope and Accessories (FDA Code: HEW / 884.1640) A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.

• Curettes (FDA Code: HTF / 878.4800)

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

• Disposable Knee Holders

• Ear Speculum (FDA Code: EPY / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Ear Spoon (FDA Code: JZE / 874.4420)

• Ear Suction Tube (FDA Code: JZF / 874.4420)

• Electric Therapeutic Massager (FDA Code: ISA / 890.5660) A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

• Electrical Recording Cystometer (FDA Code: EXQ / 876.1620) A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

• Electrode Cables (FDA Code: IKD / 890.1175) An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.

• Electrohydraulic Lithotriptor (FDA Code: FFK / 876.4480) An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Endoscope Accessories (FDA Code: KOG)

• Endoscope Cleaning Brushes & Accessories (FDA Code: MNL / 876.1500)

• Endoscopes

• Endoscopes, Stabilization and Steering

• Endoscopic Access Overtube (FDA Code: FED / 876.1500)

• Endoscopic Binocular Attachment (FDA Code: FEJ / 876.1500)

• Endoscopic Bite Blocks (FDA Code: MNK / 876.1500)

• Endoscopic Carpal Tunnel Release Systems

• Endoscopic Cleaning Accessories (FDA Code: FEB / 876.1500)

• Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS / 876.4300)

• Endoscopic Light Source

• Endoscopic Non-Prescription Lens Eyepiece (FDA Code: FEI / 876.1500)

• Endoscopic Obturator (FDA Code: FEC / 876.1500)

• Endoscopic Photographic Accessories (FDA Code: FEM / 876.1500)

• Endoscopic Prescription Lens Eyepiece (FDA Code: FDZ / 876.1500)

• Endoscopic Smoke Removal Tube (FDA Code: FCZ / 876.1500)