Profile: MicroAire Surgical Instruments LLC. provides innovative surgical solutions for improving surgeon and patient outcomes. Our product categories are power instruments, disposables, pulse lavage, carpal tunnel release, liposuction and plastic surgery. Our Turbo PAL Cannulae are single use cannulae for use with the power-assisted lipoplasty (PAL). It is sterile packaged. It provides an increased removal rate compared to standard PAL cannulae. Our EpiCut is an ergonomic handle featuring a v-shaped blade intended to remove strips of epithelial tissue. The curve of the blade helps control the depth of the strips so that vascularity of the dermis is not compromised. It is a sterile, single-use device.

The company has revenues of USD 25-50 Million, has ~120 employees and is ISO, CE certified.

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• 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)

• Adjustable Medical Cast Saws

• 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.

• Arthroscopic Accessories (FDA Code: NBH / 888.1100)

• Body Contouring Systems

• Bone Cutting Blade

• Bone Drill And Guide Forceps

• Bone Drills

• Bone Drills

• Bone Fixation Screw (FDA Code: HWC / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Burr

• Cast Cutting Saw Blade

• Cement Removal Extraction System (FDA Code: LZV / 888.4580) A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.

• Chisel/Osteotome (FDA Code: KDG / 878.4820)

• Cold Compress

• Cosmetic Microsurgical Instruments

• Cosmetic Surgery Instruments

• Durable Product Contract Manufacturing

• Electric Bone Drill

• Endoscopic Carpal Tunnel Release Systems

• Engineering/Design Service

• Gas Cylinder Pressure Regulator (FDA Code: CAN / 868.2700) A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820)

• General & Plastic Surgery Surgical Burr (FDA Code: GFF / 878.4820)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 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.

• General & Plastic Surgery Surgical Gouge (FDA Code: GDH / 878.4800)

• General & Plastic Surgery Surgical Rasp (FDA Code: GAC / 878.4800)

• General Surgical Instruments

• High Speed Drills

• Instant Cold Compresses

• Large Bone Battery Power System

• Large Bone Electric Power Systems

• Large Bone Pneumatic Power Systems

• Large Open Gear Bone Drill

• Lavage Systems

• Lipoplasty Suction System (FDA Code: MUU / 878.5040) A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.

• Micro Bone Cutting Saw

• Micro Wire Driver

• Microsurgical Instruments (FDA Code: GZX / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

• Middle Ear Surgery Drill

• Moist Heat Compress

• Orbital Procedures, Bone Drills

• Orthopaedic Instrument, Universal Bone Drill

• Orthopedic Burr (FDA Code: HTT / 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.

• Orthopedic Osteotome (FDA Code: HWM / 878.4800)

• Orthopedic Power Systems, Large Bone Battery Power System

• Orthopedic Prosthesis Implantation Instrument

• Orthopedics, High Speed Drills System

• Osteotomes