Profile: Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical devices and orthopedic surgical instruments. Our OEM brands include Beere Medical, KMedic, Deknatel and TFX OEM. We have extensive expertise in the cardiovascular, orthopedic, spinal, urology, gynecology & minimally invasive surgical specialties. Our Taut® ADAPt product line, with the addition of the universal seal ports, offers surgeons a completely bladeless laparoscopic access. The universal seal is a new approach to access for the wide variety of instruments needed in laparoscopic surgery. It provides surgeons the ability to perform procedures without torn seals, smudged cameras or the need for reducer caps. Our Arrow Pressure Injectable Triple-Lumen PICC has the ability to pressure-inject contrast media. In addition, it has central venous pressure monitoring (CVP) indication, clear and useful product labeling, a non-tapered catheter body for reduced risk of vessel occlusion, & the unique Arrow Blue FlexTip®. It is also indicated for central venous pressure monitoring, as a valuable tool for monitoring critically ill patients.
The company has revenues of USD 50-100 Million, has ~380 employees and is ISO 9001, CE certified. NYSE:TFX (SEC Filings)
FDA Registration Number: 1044475
• Non-Rebreathing Valve (FDA Code: CBP / 868.5870) A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere. |
• Non-Self-Retaining Retractor (FDA Code: FGN / 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. |
• Non-Sterile Closed Urine Drainage System For Non-Indwelling Catheter (FDA Code: NNZ / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are: |
• Non-Ventilatory Medicinal Nebulizer/Atomizer (FDA Code: CCQ / 868.5640) A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe. |
• Nut Bolt Washer (FDA Code: HTN / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. |
• 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. |
• Occlusive Wound and Burn Dressing (FDA Code: MGP) |
• Ocular Marker (FDA Code: HMR / 886.4570) An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation. |
• One-Piece Scalpel (FDA Code: GDX / 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. |
• Operating Room Scrub Brush (FDA Code: GEC / 878.4800) |
• Ophthalmic Aspiration Cannula (FDA Code: HMX / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine. |
• Ophthalmic Caliper (FDA Code: HOE / 886.4350) |
• Ophthalmic Cannula (FDA Code: HMX / 886.4350) |
• Ophthalmic Curette (FDA Code: HNZ / 886.4350) |
• Ophthalmic Eye Shield (FDA Code: HOY / 886.4750) An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place. |
• Ophthalmic Eyelid Clamp (FDA Code: HOD / 886.4350) |
• Ophthalmic Forceps (FDA Code: HNR / 886.4350) |
• Ophthalmic Headband Mirror (FDA Code: HKF / 886.1500) A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye. |
• Ophthalmic Hook (FDA Code: HNQ / 886.4350) |
• Ophthalmic Knife (FDA Code: HNN / 886.4350) |
• Ophthalmic Lens Gauge (FDA Code: HLN / 886.1420) An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens. |
• Ophthalmic Lens Radius Measuring Device (FDA Code: HLF / 886.1430) An ophthalmic contact lens radius measuring device is an AC-powered device that is a microscope and dial gauge intended to measure the radius of a contact lens. |
• Ophthalmic Manual Trephine (FDA Code: HRH / 886.4350) |
• Ophthalmic Muscle Clamp (FDA Code: HOB / 886.4350) |
• Ophthalmic Retractor (FDA Code: HNI / 886.4350) |
• Ophthalmic Ring (FDA Code: HNH / 886.4350) |
• Ophthalmic Spatula (FDA Code: HND / 886.4350) |
• Ophthalmic Speculum (FDA Code: HNC / 886.4350) |
• Ophthalmic Sponge (FDA Code: HOZ / 886.4790) An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery. |
• Ophthalmic Spud (FDA Code: HNA / 886.4350) |
• Ophthalmic Suture Scissors (FDA Code: HNF / 886.4350) |
• Ophthalmology, Surgical Instrument Trays |
• Orbital Depressor (FDA Code: HNX / 886.4350) |
• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800) |
• Orthopedic Knife (FDA Code: HTS / 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. |
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) |
• Orthopedic Needle Holder (FDA Code: HXK / 888.4540) |
• Orthopedic Osteotome (FDA Code: HWM / 878.4800) |
• Otoscopes (FDA Code: ERA / 874.4770) An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system. |
• Oximeters (FDA Code: DQA / 870.2700) An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter. |
• Oximeters |
• Oxygen Analyzers |
• Oxygen Cylinder Carts |
• Oxygen Cylinder Stands & Bases |
• Oxygen Cylinders |
• Oxygen Filters |
• Oxygen Flow Meters |
• Oxygen Masks (FDA Code: BYG / 868.5580) An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. |
• Oxygen Monitors and Analyzers |
• Oxygen Nasal Cannula (FDA Code: CAT / 868.5340) A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils. |