Profile: Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surgery, surgical sutures, sterile, storage, engine or navigation systems as well as products for cardiology. The neuro surgical product includes instrument for bipolar coagulation, bone flap fixation, cerebro vascular clips, duraersatz, high speed drill, hydrocephalus shunt and instruments for neuroendoscopy. We provide motor systems for a variety of indications such as orthopedics, arthroscopy, neurosurgery and spinal surgery. We offer a wide selection of products and services for interventional cardiology and vascular surgery such as angiography, angioplasty, electrophysiology, hemodynamics in the catheterization laboratory, vena cava filter, vascular implants and specialties.

FDA Registration Number: 9610612
US Agent: Robin Fatzinger / Aesculap, Inc.
Phone: +1-(610)-984-9067  Fax: +1-(610)-791-6882  E-Mail:

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• Surgical Cutter (FDA Code: FZT / 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 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 Hammer (FDA Code: FZY / 878.4800)

• Surgical Headband Light (FDA Code: FSR / 886.4335) An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

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

• Surgical Knife (FDA Code: EMF / 878.4800)

• Surgical Metal Tongue Depressor (FDA Code: KBL / 874.4420)

• Surgical Orthopedic Scissors (FDA Code: HRR / 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.

• Surgical Pliers (FDA Code: HTC / 878.4800)

• Surgical Punch (FDA Code: LRY / 878.4800)

• Surgical Razor (FDA Code: LWK / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Skin Markers (FDA Code: FZZ / 878.4660) A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.

• Surgical Staple Applier (FDA Code: GEF / 878.4800)

• Surgical Stripper (FDA Code: HRT / 888.4540)

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

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Suture Retention Device (FDA Code: KGS / 878.4930) A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.

• Table Operating Room Accessories (FDA Code: FWZ / 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.

• Tamps (FDA Code: HXG / 888.4540)

• Templates (FDA Code: HWT / 888.4800) A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

• Temporary Pacemaker Electrode (FDA Code: LDF / 870.3680) A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

• Tongue Depressors (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• Tonsil Dissector (FDA Code: KBM / 874.4420)

• Tonsil Knife (FDA Code: KBQ / 874.4420)

• Tonsil Punch (FDA Code: KBT / 874.4420)

• Tonsil Snares (FDA Code: KBZ / 874.4420)

• Tonsil Suturing Needle (FDA Code: KBR / 874.4420)

• Tonsillectome (FDA Code: KCA / 874.4420)

• Topical Approximation of Skin Tissue Adhesive (FDA Code: MPN / 878.4010)

• Tuning Forks (FDA Code: GWX / 882.1525) A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.

• Two-point Discriminator (FDA Code: GWI / 882.1200) A two-point discriminator is a device with points used for testing a patient's touch discrimination.

• Ultrasonic Surgical Instrument (FDA Code: LFL)

• Umbilical Scissors (FDA Code: HDJ / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ / 888.3360) A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

• Uncemented, Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LZO / 888.3353) A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

• Unipolar Endoscopic Coagulator-cutter and Accessories (FDA Code: KNF / 884.4160) A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

• Urological Bougie (FDA Code: FAX / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

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

• Uterine Clamp (FDA Code: HGC / 884.4520)

• Uterine Curettes (FDA Code: HCY / 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:

• Uterine Packer (FDA Code: HDM / 884.4520)

• Uterine Sounds (FDA Code: HHM / 884.4530)

• Vacuum Regulator (FDA Code: KDP / 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).

• Vaginal Retractors (FDA Code: HDL / 884.4520)

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

• Ventricular Cannula (FDA Code: HCD / 882.4060) A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.