The company was founded in 1977, has revenues of USD 1-5 Million, has ~120 employees.
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|• (FDA Code: LGH / 888.5960)|
A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.
|• (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.
|• (FDA Code: GEY / 878.4820)|
|• (FDA Code: EWC / 874.1060)|
An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.
|• (FDA Code: KBJ / 874.4420)|
|• (FDA Code: KBS / 874.4420)|
|• (FDA Code: KBH / 874.4420)|
|• (FDA Code: FZM / 878.4950)|
A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.
|• (FDA Code: FMA / 880.6230)|
A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.
|• (FDA Code: HGE / 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:
|• (FDA Code: GDN / 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.
|• (FDA Code: CAE / 868.5110)|
An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.
|• (FDA Code: HCH / 882.5200)|
An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.
|• (FDA Code: HCI / 882.4175)|
An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.
|• (FDA Code: DXT / 870.1650)|
An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.
|• (FDA Code: FER / 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.
|• (FDA Code: KAT / 874.4420)|
|• (FDA Code: KAW / 874.4420)|
|• (FDA Code: DXC / 870.4450)|
A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.
|• (FDA Code: NBH / 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.
|• (FDA Code: JYX / 874.4420)|
|• (FDA Code: GAG / 878.4800)|
|• (FDA Code: HWJ / 888.4540)|
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
|• (FDA Code: MAV / 870.1650)|
|• (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).
|• (FDA Code: HPP / 886.4335)|
An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.
|• (FDA Code: HJN / 886.1945)|
A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.
|• (FDA Code: FOB / 880.6730)|
A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.
|• (FDA Code: HXP / 888.4540)|
|• (FDA Code: KNW / 876.1075)|
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
|• (FDA Code: KNW / 876.1075)|
|• (FDA Code: FCI / 876.1075)|
|• (FDA Code: FCI / 876.1075)|
|• (FDA Code: HIN / 884.4150)|
A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.
|• (FDA Code: FHK / 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.
|• (FDA Code: FMK / 878.4800)|
|• (FDA Code: BYO / 868.5220)|
A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another.
|• (FDA Code: HXD / 878.4800)|
|• (FDA Code: HWC / 888.3040)|
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.