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

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• Hot/Cold Water Bottle (FDA Code: FPF / 880.6085) A hot/cold water bottle is a device intended for medical purposes that is in the form of a container intended to be filled with hot or cold water to apply heat or cold to an area of the body.

• Human 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.

• Humidification Kits

• Humidification System

• Humidifiers

• Hydraulic Cystometric Device (FDA Code: FEN / 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.

• Illuminated Speculum (FDA Code: FXF / 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.

• Impactor (FDA Code: HWA / 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.

• Implantable Clip (FDA Code: FZP / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Incandescent Endoscopic Lamp (FDA Code: FTI / 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.

• Inflatable Tracheal Tube Cuff (FDA Code: BSK / 868.5750) An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

• Inflation Bulb For Endoscope (FDA Code: FCY / 876.1500)

• Instestinal Clamp Locking Device (FDA Code: FFR / 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.

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Intermittent Mandatory Ventilation (IMV) Attachment (FDA Code: CBO / 868.5955) An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.

• Internal Gauze/Sponge (FDA Code: EFQ)

• Internal Surgical Tape (FDA Code: MCA / 878.3300)

• Intraluminal Artery Stripper (FDA Code: DWX / 870.4875) An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

• Intravascular Catheter Securement Device (FDA Code: KMK / 880.5210) An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.

• Iris Retractor Clip (FDA Code: HOC / 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.

• Irrigation Catheter (FDA Code: GBX / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Lacrimal Dilator (FDA Code: HNW / 886.4350)

• Lacrimal Probes (FDA Code: HNL / 886.4350)

• Lacrimal Sac Rongeur (FDA Code: HNG / 886.4350)

• Laparoscopic Insufflator (FDA Code: HIF / 884.1730) A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

• Laparoscopic Probes

• Laparotomy Rings (FDA Code: FHI / 876.4730)

• Laryngeal Knife (FDA Code: JZY / 874.4420)

• Laryngectomy Tube (FDA Code: KAC / 874.4420)

• Laryngoscope/Nasopharyngoscope (FDA Code: EQN / 874.4760) A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

• Laser Power Probe

• Ligature Carrier (FDA Code: GEJ / 878.4800)

• Ligature Carrier Set (FDA Code: GEJ / 878.4800)

• Ligature Clip

• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800)

• Magnetic Locator (FDA Code: FTZ / 886.4445) A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

• Male External Catheters

• Malecot Catheters (FDA Code: FEW / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

• Malleus Nipper (FDA Code: JYR / 874.4420)

• Manual Cast Application and Removal Instrument (FDA Code: LGG / 888.5980) A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand.

• Manual Corneal Burr (FDA Code: HOF / 886.4350)

• Manual Emergency Ventilator/Resuscitator (FDA Code: BTM / 868.5915) A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 876.4730)

• Manual Osteotome (FDA Code: GFI / 878.4800)

• Manual Rongeur (FDA Code: HAE / 882.4840) A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)

• Manual Surgical Instrument

• Manual Tonometer (FDA Code: HKY / 886.1930) A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

• Mastoid Chisel (FDA Code: JYD / 878.4800)