Profile: Bionix Development Corporation develops, manufactures and markets medical devices. Our articulating safe ear curette™ is the only curette that articulates to assist in the removal of cerumen from the ear canal. It works because of the unique living hinge at the tip & the split handle design. Once positioned beyond an obstructive cerumen plug, usually through a space between the ear canal wall & the plug, the tip can be articulated by simply sliding the forefinger and thumb in opposite directions. The cerumen can then be pulled straight from the ear canal without using a blind sweeping motion.

The company was founded in 1984, has revenues of USD 1-5 Million, has ~40 employees.

FDA Registration Number: 1526854

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• ENT Irrigation Syringe (FDA Code: KCP / 874.5220) An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

• ENT Syringe (FDA Code: KCP / 874.5220)

• External Limb Component Knee Joint (FDA Code: ISY / 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.

• Eye Dressing Forceps

• Feeding Needles (FDA Code: FNN / 880.5640) A lamb feeding nipple is a device intended for use as a feeding nipple for infants with oral or facial abnormalities.

• Flat Handle Forceps Tying Forceps

• Flexible Biopsy Forceps

• Flexible Rat-Tooth Grasping Forceps

• Forceps (FDA Code: HTD / 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.

• Forceps Epilation Angled End

• Forceps Needle Holders

• Forceps Tips Angled Tips

• Forceps Tips, Broad

• Forceps Tips, Curved

• Forceps Tips, Straight

• Gastrointestinal String and Tubes (FDA Code: FFW / 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).

• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980)

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

• General Hypodermic Supplies

• General Medical Supplies

• General Surgical Aids

• Hardy Bayonet Forceps

• Inferior Oblique Muscle Forceps

• Intraocular Foreign-Body Forceps

• Iris Suturing Forceps

• Iris Tissue Forceps

• Jeweler Type Forceps

• Kleppinger Forceps

• Kremer Angled Fixation Forceps

• Kremer Corneal Fixation Forceps

• Lacrimal System, Bayonette Forceps

• Left-handed Halsted-Mosquito. Hemostatic Forceps

• Lighted Ear Curettes

• Long Cilia Forceps

• Long Handle Curettes

• Manual Patient Transfer Device (FDA Code: FMR / 880.6785) A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher.

• Medical Charged-Particle Radiotherapy Unit (FDA Code: LHN / 892.5050) A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

• Medical Linear Accelerator (FDA Code: IYE / 892.5050)

• Micro Axial Curettes

• Micro Suturing Forceps

• Micro Utility Forceps with Spring-lock

• Microsurgical Bipolar Forceps

• modified bayonet Forceps

• Modified Watchmaker's Forceps

• Nasal & Ear Specula

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Non-Cantilevered Ringed Forceps

• Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF / 880.6025) An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• Obstetrical Forceps (FDA Code: HDA / 884.4400) An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.

• Open Biopsy Forceps