Profile: Applied Medical is associated with clinical areas such as general surgery, urology, vascular, cardiac, colorectal and Ob/Gyn surgery. We have introduced GelPort® laparoscopic system, Kii® abdominal access system, Acucise® endopyelotomy/endoureterotomy system, Direct Drive® graspers and Alexis® wound retractor/protector. Our Alexis® and Alexis O™ wound retractors provide 360° of circumferential, atraumatic retraction while decreasing wound infection. They provide maximum exposure for open procedures, while minimizing the incision size. They are instrumental in offering retraction and protection when an organ or specimen requires removal through a small incision in a laparoscopic surgery.

The company was founded in 1987, has revenues of USD 100-500 Million, has ~1000 employees and is ISO, CE certified.

FDA Registration Number: 2027111

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• Active Electrosurgical Electrode (FDA Code: FAS / 876.4300) 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.

• Angiographic Injector and Syringe (FDA Code: DXT / 870.1650) An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.

• Angioscope (FDA Code: LYK / 876.1500) 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.

• Arterial Embolectomy Catheter

• Artery Vascular Clamp (FDA Code: DXC / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

• Cardiac Fetal Monitor (FDA Code: KXN / 884.2600) A fetal cardiac monitor is a device used to ascertain fetal heart activity during pregnancy and labor. The device is designed to separate fetal heart signals from maternal heart signals by analyzing electrocardiographic signals (electrical potentials generated during contraction and relaxation of heart muscle) obtained from the maternal abdomen with external electrodes. This generic type of device may include an alarm that signals when the heart rate crosses a preset threshold. This generic type of device includes the "fetal cardiotachometer (with sensors)" and the "fetal electrocardiographic monitor."

• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• 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 Tip Occluder (FDA Code: DQT / 870.1370) A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.

• Cholangiography Catheters (FDA Code: GBZ / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Diagnostic Biliary Catheter (FDA Code: FGE / 876.5010) A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

• Disposable Laparoscopic Scissors

• Disposable Surgical Drape (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.

• Disposable Surgical Instrument (FDA Code: KDC / 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.

• Embolectomy Catheters (FDA Code: DXE / 870.5150) An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Access Overtube (FDA Code: FED / 876.1500)

• Flexible Stone Dislodger (FDA Code: FGO / 876.4680) A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

• Flexible/Rigid Choledochoscope and Accessories (FDA Code: FBN / 876.1500)

• Flexible/Rigid Ureteroscope and Accessories (FDA Code: FGB / 876.1500)

• Fluid Evacuator System (FDA Code: FHF / 876.4370) A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

• Gastro-Urology Catheter & Accessories (FDA Code: KNY / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Gastro-Urology Hook (FDA Code: FHB / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Gastro-Urology Needle (FDA Code: FHR / 878.4800)

• Gastro-Urology Stylet (FDA Code: EZB / 876.5130)

• Gastro-Urology Ureteral Catheter (FDA Code: EYB / 876.5130)

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800)

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• Graspers

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Implantable Clip (FDA Code: FZP / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Insert Clamps

• Intraluminal Artery Stripper (FDA Code: DWX / 870.4875) An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

• Irrigation Catheter (FDA Code: GBX / 878.4200)

• Laparoscopic Clip Appliers

• Laparoscopic Insufflator (FDA Code: HIF / 884.1730) A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

• Laparoscopic Retrieval Systems

• Laparoscopic Suction/Irrigation Equipment

• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 876.4730)

• Miscellaneous Endoscope Bulb Adaptor (FDA Code: FFY / 876.1500)

• Non-Powered Surgical Instrument (FDA Code: HAO / 882.4535) A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

• Percutaneous Catheter (FDA Code: DQY / 870.1250) A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

• Pressure Tubing and Accessories (FDA Code: BYX / 868.5860) Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

• Rigid Endoscopes (FDA Code: GCM / 876.1500)

• Single-Function Pre-Programmed Diagnostic Computer (FDA Code: DXG / 870.1435) A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

• Specialized Obstetric-Gynecologic Manual Instrument (FDA Code: KNA / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

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

• Structural Balloon Trocars