Profile: CFI Medical Solutions is a manufacturing powerhouse and a cutting-edge engineering resource for original equipment manufacturers (OEMs). Our product categories are medical imaging, operating accessories and rehabilitation. Our product list comprises of ear laminograph block, replacement straps for the shield, table pad, patient transfer boards, surgical table pads and knee spreader. The knee spreader is used to keep the legs separated when sitting in a wheelchair or bed. It is equipped with Velcro® fasteners. The knee spreader is designed to separate the patient's legs while they are lying on their side.

The company was founded in 1970, has revenues of USD 10-25 Million, has ~300 employees and is ISO 13485:2003, CE certified.

FDA Registration Number: 1825560

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• Surgical Camera and Accessories (FDA Code: KQM / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Surgical Camera without Audio (FDA Code: FWH / 878.4160)

• Surgical Cine Camera With Audio (FDA Code: FWI / 878.4160)

• Surgical Drapes (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)

• Surgical Instrument Tray (FDA Code: FSM / 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 Microscopes (FDA Code: EPT / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

• Surgical Still Camera (FDA Code: FTT / 878.4160)

• Surgical Table Cushion (FDA Code: LWG / 878.4950) 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.

• Surgical Table Pads

• Surgical Television Camera with Audio (FDA Code: FWC / 878.4160)

• Surgical Television Camera without Audio (FDA Code: FWB / 878.4160)

• Table Operating Room Accessories (FDA Code: FWZ / 878.4950)

• Table Scatter Shield

• 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.

• Urology Surgical Drapes (FDA Code: KKX / 878.4370)

• Vacuum Immobilization Infant Splint

• X-Ray Accessories, Leaded Aprons (FDA Code: EAJ / 892.6500) A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.