Profile: Instrumed, Inc. develops and markets medical devices used during orthopedic surgery of the arms & legs. We manufacture orthopedic surgical equipment, urological stents, urological surgical catheters, ear protectors, anastomosis rings, surgeon utensil sets or cabinets, orthopedic bone smoothers & endoscopic adapters. We offer smartpump single channel, tourniquet report printer and color cuff I reusable. Our accessories include limb protection sleeve, sterile extension tubing and adapters. Our color cuff II sterile disposable tourniquets are used to eliminate the risk of cuff-borne cross contamination.

NYSE:SYK (SEC Filings)

FDA Registration Number: 1811755

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• AC-Powered Cast Removal Instrument (FDA Code: LGH / 888.5960) A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.

• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 878.4820) 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.

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

• Acrylic Bone Cement

• Adhesive Bandage Strip

• Adhesive Bandages (FDA Code: KGX / 880.5240) 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.

• Adult-Pediatric Volumetric Infusion Pumps

• Ambulatory Infusion Pumps

• Anesthesia Infusion Pump Tubing

• Anesthetic Conduction Catheter (FDA Code: BSO / 868.5120) An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

• Anesthetic Infusion Pump (FDA Code: FRN / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Anti-Fog Surgical Mask with Adhesive Tape

• Antibiotic Bone Cement (FDA Code: MBB / 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.

• Antibiotic Impregnated Bone Cement

• Arthroscopes (FDA Code: HRX / 888.1100) An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

• Autotransfusion Apparatus (FDA Code: CAC / 868.5830) An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

• Barrier Reusable Surgical Gowns

• Batteries & Battery Assemblies for Infusion Pumps

• Bioreabsorbable Bone Cement

• Blastomyces Dermatitidis EIA (FDA Code: MJL / 866.3060)

• Bone Cement (FDA Code: LOD / 888.3027)

• Bone Cement Mixing Systems

• Bone Cement Radiopacifier

• Bone Cement Removal Devices

• Bone Cement Restrictor

• Brushite Bone Cement

• Burr

• Calcium Phosphate Bone Cements

• Cardiovascular Surgical Saw Blade (FDA Code: DWH / 878.4820)

• Cast Component (FDA Code: LGF / 888.5940) A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.

• Cast Covers (FDA Code: KIA / 880.6185) A cast cover is a device intended for medical purposes that is made of waterproof material and placed over a cast to protect it from getting wet during a shower or a bath.

• Catheter Introducers (FDA Code: DYB / 870.1340) A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

• Catheter Introducers, MULLINS

• Catheter Introducers, Mullins Design

• Ceiling-Mounted, Surgical Helmet Systems

• Cement Dispenser (FDA Code: KIH / 888.4200) A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

• Cement Mixing Equipment (FDA Code: JDZ / 888.4210) A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (888.3027).

• Cement Monomer Vapor Evacuator (FDA Code: JDY / 888.4220) A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (888.3027).

• Cement Obturator (FDA Code: LZN / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Cement Restrictor Hip Prosthesis (FDA Code: JDK / 878.3300)

• Cervical Orthosis (FDA Code: IQK / 890.3490) A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

• Cone Surgical Mask

• Constant-flow Infusion Pump

• Curettes (FDA Code: HTF / 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.

• Dermabrasion Brush (FDA Code: GFE / 878.4820)

• Dermatomes (FDA Code: GFD / 878.4820)

• Disposable Tourniquet Cuffs

• Disposable/Reusable Surgical Suit (FDA Code: FXO / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

• Dual Channel Tourniquet

• Dual-Channel Volumetric Infusion Pump