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
• Umbilical Occlusion Device (FDA Code: FOD / 880.5950) An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant. |
• Umbilical Scissors (FDA Code: HDJ / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following: |
• Ureteral Catheter Connector (FDA Code: EYK / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use). |
• Ureteral Splint (FDA Code: FAD / 876.4620) A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction. |
• Urethral Catheters (FDA Code: GBM / 876.5130) |
• Urinary Leg Bags |
• Urine Collection Leg Bags (FDA Code: FAQ / 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: |
• Urine Leg Bags (FDA Code: FAQ / 876.5250) |
• Urological Bougie (FDA Code: FAX / 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. |
• Urological Catheters (FDA Code: KOD / 876.5130) |
• Urological Drain Bags |
• Urological Male External Catheters |
• Urological Tubing & Connectors |
• Uterine Clamp (FDA Code: HGC / 884.4520) |
• 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 Elevator (FDA Code: HDP / 884.4530) |
• Uterine Sounds (FDA Code: HHM / 884.4530) |
• Uterine Tenaculum (FDA Code: HDC / 884.4530) |
• Vacuum Collection Bottle (FDA Code: KDQ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). |
• 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. |
• Vaginal Retractors (FDA Code: HDL / 884.4520) |
• Vascular Clamps (FDA Code: DXC / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily. |
• Vascular Clips (FDA Code: DSS / 870.3250) A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels. |
• Vena Cava Clip (FDA Code: DST / 870.3260) A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboemboli through that vessel. |
• Ventilator Tubing and Support Set (FDA Code: BZO / 868.5975) Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient. |
• Ventricular Catheters (FDA Code: HCA / 882.4100) A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. |
• Venturi Low Concentration Oxygen Mask (FDA Code: BYF / 868.5600) A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient. |
• Wall Vacuum-Powered Operating Room Suction Apparatus (FDA Code: GCX / 880.6740) |
• Water Jet Lavage Unit (FDA Code: FQH / 880.5475) A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump. |
• Wire Cutters (FDA Code: HXZ / 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. |
• Wire Loop (FDA Code: JYQ / 874.4420) |
• Wire Twisters (FDA Code: HXS / 888.4540) |
• Wrench (FDA Code: HXC / 888.4540) |
• Xenon Arc Endoscope Light Source (FDA Code: GCT / 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. |
• 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. |