3-Dimensional Camera System,A-Scan Ultrasound Devices Suppliers & Manufacturers

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3-Dimensional Camera System
Luxtec, Olympus America, Inc.

A-Scan Ultrasound Devices
Nidek Inc., Ambassador Medical, LLC, Covidien, more...

A-v Fistula Clamp
Codman & Shurtleff, Inc., Wenzhou K.L.F. Medical Plastics Co., Ltd.

Abdominal Suction Tube
Sunrise Medical, U.S.E Surgical Instruments, Medovations, Inc., more...

Ablation Catheter
Ablation catheter is used to remove a faulty electrical pathway from the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter and supraventricular tachycardias. It involves advancing several flexible catheters into the patient's blood vessels, usually either in the femoral vein and internal jugular vein, or subclavian vein.
Biosense Webster, Inc., Bard Electrophysiology, C. r. Bard, Inc., more...

Absorbable Adhesion Barrier (FDA Code: MCN)
Autosuture, Genzyme Biosurgery, Ethicon, Inc., more...

Absorbable Collagen Hemostatic Sponge
Integra LifeSciences Corporation, Biocell Laboratories, Inc., Medtronic Sofamor Danek Instrument Manufacturing, more...

Absorbable Gauze, Dressing
DeRoyal Industries, Carwild Corporation, Derma Sciences, Inc., more...

Absorbable Laparoscopy Suture
Autosuture, Zimmer, Inc., Ethicon, Inc., more...

Absorbable Surgical Films (FDA Code: OOD)
Tepha, Incorporated

Absorbable Surgical Sutures
Absorbable surgical suture is a surgical suture material prepared from a substance that can be dissolved by body tissues and is therefore not permanent; it is available in various diameters and tensile strengths; the rate of dimunition of strength depends on the characteristics of the suture material.
W. l. Gore & Associates, Inc., Starmedix LLC, Alimed, Inc., more...

Absorbable Suture Screwed Anchor
Autosuture, Ethicon, Inc., CP Medical, Inc, more...

Absorbable Sutures (FDA Code: GAK / 878.4830)
Absorbable Sutures are made of materials, which are broken down in tissue after a given period of time. Absorbable sutures are made of the intestines of sheep, called catgut. Absorbable sutures provide temporary wound support, until the wound heals well enough to withstand normal stress. Absorbable sutures are used to close skin but only in a subcuticular or completely buried pattern.

Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA." See 878.1(e) for the availability of this guidance document.

Autosuture, Southpointe Surgical Supply, Inc., Alimed, Inc., more...

AC-Powered Endoscope and Accessories (FDA Code: GCP / 876.1500)

Identification. 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.

Classification. (1) Class II (performance standards).

Laserscope, Codman & Shurtleff, Inc., Welch Allyn, Inc., more...

AC-Powered Fluorescein Lamp (FDA Code: HJE / 878.4580)

Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Classification. Class II.

Autosuture, Bulbtronics, Inc, Welch Allyn, Inc., more...

AC-Powered Operating Room Table (FDA Code: FQO / 878.4960)

Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.

Laserscope, Future Health Concepts, Inc., DRE, Inc., more...

AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX / 878.4780)

Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Classification. Class II.

Depuy Orthopaedics, Inc., Viasys Healthcare Inc, DNTLworks Equipment Corporation, more...

AC-Powered Surgical Chair (FDA Code: GBB / 878.4960)

Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.

Elmed Inc., Stille Surgical, Inc., Jedmed Instrument Company, more...

AC-Powered Surgical Instrument Motor (FDA Code: GEY / 878.4820)

Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.

Depuy Orthopaedics, Inc., Abbott Vascular Devices, Medtronic Xomed Surgical Products, Inc, more...

AC-Powered Surgical With Orthopedic Accessories Table (FDA Code: JEA / 878.4960)

Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.

Mizuho OSI, DRE, Inc., Getinge USA, Inc., more...

Active Electrosurgical Electrode (FDA Code: FAS / 876.4300)

Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Classification. Class II (performance standards).

Viasys Healthcare Inc, Advanced Bionics Corporation, Valleylab, more...

Acupuncture Chart
Lhasa Oms, Inc.

Adhesive Bandage Strip
Kerr Corporation, Lifescience Plus, Inc., Swift First Aid, more...

Adhesive Bandages (FDA Code: KGX / 880.5240)

Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9.

Merit Pharmaceutical, Inc., Kerr Corporation, Tellus Medical Products, Inc., more...

Adhesive Strips & Patches
Tellus Medical Products, Inc., Evercare Company, The, Nutramax Products, Inc., more...

Adhesive Tape Solvent (FDA Code: KOX / 878.4730)

Identification. A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

Elantec Medical, Inc., Autosuture, Aspen Surgical Products, more...

Adhesive Wound Skin Closures
Adhesive wound skin closures offer important benefits over other wound closure methods including atraumatic application, more cost-effective than sutures, improved cosmetic results, reduced potential for infection and quicker development of wound tensile strength.
American Medical Sales, Inc., KCK Medical, Autosuture, more...

Adjustable Operating Room Stool (FDA Code: FZM / 878.4950)

Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

Galaxy Salon Furniture & Equipment, Allergan, Inc, Allen Medical Systems, more...

Adson Elevator
Codman & Shurtleff, Inc., Wellknown Instruments, AAKK Surgical Corporation, more...

Adson Needle Holder
ArosurgicalT Instruments Corporation, Elmed Inc., Zimmer, Inc., more...

Adult Cricothyrotomy Kit
Cook Group Incorporated, Smiths Medical ASD, Inc, Gilbert Surgical Instruments, more...

Adult Patient Gowns
Arizant Healthcare Inc., Assisted Living Store, Inc., Personal Touch Health Care Apparel Inc., more...

Aerosol Adhesive Drape (FDA Code: KGT / 878.4380)

Identification. A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

Lifescience Plus, Inc., Viasys Healthcare Inc, Ferndale Laboratories, Inc., more...

Aesthetic Dermal Implant (FDA Code: LMH)
Byron Medical, Inc., Genzyme Biosurgery, Artes Medical, Inc., more...

Agar Cutting Needles
Iscon Surgicals Limited

Air Handling Apparatus (FDA Code: FZG / 878.5070)

Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

Classification. Class II.

Airex, Inc.

Airway Management
Airway management involves ensuring that the patient has a patent airway through which effective ventilation can take place. It consists of much more than just keeping the breathing tube in the correct position. The tube must be managed so that it allows optimal ventilation with the fewest complications.
Engineered Medical Systems, Inc., Cook Urological, Achi Corp., more...

Airway Management, Adult Bronchoscope
Engineered Medical Systems, Inc., Cook Urological

Airway Management, ET Tubes
An endotracheal tubes are used in anaesthesia, intensive care and emergency medicine for airway management and mechanical ventilation. The tube is inserted into a patient's trachea in order to ensure that the airway is not closed off and that air is able to reach the lungs. The endotracheal tube is regarded as the most reliable available method for protecting a patient's airway.
Engineered Medical Systems, Inc., Cook Urological, Kimberly-Clark Corporation

Airway Management, Fiber Bronchoscope
Fiber bronchoscope is designed to provide bright, high-resolution images and excellent optical characteristics. It also provides a wider field of view, a smaller insertion tube and distal end diameter and greater tip bending range all for easier operation during surgical procedures.
Engineered Medical Systems, Inc., Cook Urological

Airway Management, Pediatric Bronchoscope
Engineered Medical Systems, Inc., Cook Urological

Airway Management, Therapeutic Bronchoscope
Therapeutic bronchoscopy is used for endobronchial staging of lung cancer and symptomatic relief of central airway obstruction or postobstructive pneumonia.
Engineered Medical Systems, Inc., Cook Urological

Airways & Bite Blocks, Bite Guards and Blocks
Hudson RCI, GI Supply, Safestitch Medical, more...

Airways & Bite Blocks, Fiberoptic Intubating Airway
Hudson RCI, GI Supply, Somatics, LLC, more...

Airways & Bite Blocks, Oral Airways
Hudson RCI, GI Supply, Somatics, LLC, more...

Algesimeter
Kaisers Surgical Instruments Pty Ltd

Allergy Syringe Organizer
Becton, Dickson & Co.,, Medical Supplies & Equipment Company LLC, IBL International GmbH

Allergy Syringes/Trays
Allergy syringes are used to give allergens to patients.
Inviro Medical, Covidien, Becton, Dickson & Co.,, more...

Alligator Forceps
Rusch Inc., Autosuture, High Class Dental, more...

Ambulatory Pumps
Ambulatory Pumps are used in hospital & home care settings for the delivery of analgesics & chemotherapeutics and for the treatment of spaticity & diabetes. It uses 9-volt batteries. This pump offer improved drug stability and controlled delivery. Ambulatory pumps are small portable pumps that deliver the chemotherapy drug during normal daily activities.
Bristol Med Wholesale, HR Medical, Baxter International Inc, more...

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