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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• Patient Care Suction Apparatus (FDA Code: DWM / 870.5050) A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.

• Patient Controlled Analgesia (PCA) Infusion Pump (FDA Code: MEA / 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.

• PCA Pumps, Infusion Pump

• Peristaltic Infusion Pump (FDA Code: FRN / 880.5725)

• Piston Syringe (FDA Code: FMF / 880.5860) A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

• Pneumatic Drill Motor (FDA Code: HBB / 882.4370) A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

• Pneumatic Powered Orthopedic Surgical Instrument & Accessory (FDA Code: HSZ / 878.4820)

• Pneumatic Tourniquet (FDA Code: KCY / 878.5910) A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

• Pneumatic-Powered Surgical Instrument Motor (FDA Code: GET / 878.4820)

• Pneumatically Powered Saw (FDA Code: KFK / 878.4820)

• Powered Saw and Accessories (FDA Code: HAB / 878.4820)

• Pre Filled Bone Cement Mixer

• Probes (FDA Code: HXB / 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.

• Product Development, Hand-held Infusion Pump Controller

• Product Development, Infusion Pumps

• Protective Surgical Hood (FDA Code: FXY / 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.

• Reusable Surgical Gowns

• Reusable Tourniquets

• Simple Powered Trephines & Accessories (FDA Code: HBE / 882.4310) Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

• Simplex Tobramycin Bone Cement

• Single Channel Tourniquet

• Sinus Cannula (FDA Code: KAM / 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.

• Soft Tissue Biodegradable Fixation Fastener (FDA Code: MAI / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Sterile Extension Tubing

• Sterile Specimen Trap (FDA Code: BYZ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Sterilization Wrap Containers (FDA Code: KCT / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

• Suction Canister Systems

• Surgical Apparel Accessories (FDA Code: LYU / 878.4040)

• Surgical Bit (FDA Code: GFG / 878.4820)

• Surgical Exhaust Apparatus (FDA Code: FYD / 878.5070) 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.

• Surgical Gowns

• Surgical Gowns (FDA Code: FYA / 878.4040)

• Surgical Helmet (FDA Code: FXZ / 878.4040)

• Surgical helmet system (SHS)

• Surgical Helmet Systems

• Surgical Hood (FDA Code: FXY / 878.4040)

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Lamps (FDA Code: FTD / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Surgical Lights (FDA Code: FTD / 878.4580)

• Surgical Mask for Nurses

• Surgical Masks (FDA Code: FXX / 878.4040)

• Surgical Needle Guide (FDA Code: GDF / 878.4800)

• Surgical Suite

• Syringe Infusion Pump

• Therapeutic Intravascular Catheter (FDA Code: LJS / 880.5970) A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

• Tie-On Surgical Masks

• Tourniquet System

• Tourniquet with Pump

• Tourniquets

• Traditional Bone Cements