Profile: Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays.

FDA Registration Number: 9680904
US Agent: Jane Weber / Carefusion 2200, Inc.
Phone: +1-(847)-362-8094  Fax: +1-(312)-949-0583  E-Mail:

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• Surgical Pliers (FDA Code: HTC / 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.

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Stripper (FDA Code: HRT / 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.

• Surgical Stylet (FDA Code: GAH / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Vessel Dilator (FDA Code: DWP / 870.4475) A surgical vessel dilator is a device used to enlarge or calibrate a vessel.

• Tamps (FDA Code: HXG / 888.4540)

• Tee Drain/Water Trap (FDA Code: BYH / 868.5995) A tee drain (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy, thereby preventing an increase in breathing resistance.

• Therapeutic Incentive Spirometer (FDA Code: BWF / 868.5690) An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.

• Tongue Depressors (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.

• Tonsil Dissector (FDA Code: KBM / 874.4420)

• Tonsil Knife (FDA Code: KBQ / 874.4420)

• Tonsil Punch (FDA Code: KBT / 874.4420)

• Tonsil Snares (FDA Code: KBZ / 874.4420)

• Tonsil Suturing Hook (FDA Code: KBP / 874.4420)

• Tracheal Dilators (FDA Code: KCG / 874.4420)

• Tracheal Tube Fixation Device (FDA Code: CBH / 868.5770) A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.

• Tracheal Tube with/without Connector (FDA Code: BTR / 868.5730) A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

• Tracheobronchial Suction Catheter (FDA Code: BSY / 868.6810) A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

• Tracheostomy Tube and Cuff (FDA Code: JOH / 868.5800) A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

• Tracheostomy Tube with/without Connector (FDA Code: BTO / 868.5800)

• Tube Introduction Forceps (FDA Code: BWB / 868.5780) Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea.

• Two-point Discriminator (FDA Code: GWI / 882.1200) A two-point discriminator is a device with points used for testing a patient's touch discrimination.

• Ultrasonic Blood Flow Monitor (FDA Code: HEP / 884.2660) A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

• Ultrasonic Fetal Monitor (FDA Code: KNG / 884.2660)

• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560) An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Ultrasonic Pulsed Doppler Imaging System (FDA Code: IYN / 892.1550) An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Ultrasonic Transducer (FDA Code: JOP / 870.2880) An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

• 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:

• Urethrotome (FDA Code: EZO / 876.4770) A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.

• 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.

• 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 Packer (FDA Code: HDM / 884.4520)

• Uterine Sounds (FDA Code: HHM / 884.4530)

• Uterine Tenaculum (FDA Code: HDC / 884.4530)

• Uterotubal Carbon-Dioxide Insufflator and Accessories (FDA Code: HES / 884.1300) A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.

• 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.

• Venous Blood-Pressure Manometer (FDA Code: KRK / 870.1140) A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.

• 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.

• Ventilatory Effort Recorder (FDA Code: MNR / 868.2375) A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in 868.2377.

• Ventricular Cannula (FDA Code: HCD / 882.4060) A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.

• 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.

• Vertebroplasty (Does Not Contain Cement) Injector (FDA Code: OAR / 888.4200) A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

• Vertebroplasty Bone Cement (FDA Code: NDN / 888.3027) Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

• Vertebroplasty Spinal Channeling Instrument (FDA Code: OCJ / 888.4540)