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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• Non-Electrical Clamp (FDA Code: FFN / 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.

• Non-Invasive Tubing (FDA Code: GAZ / 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).

• Non-Powered Dynamometer (FDA Code: HRW / 888.1250) A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

• Non-Powered Goniometer (FDA Code: KQW / 888.1520) A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

• Non-Powered Rectal Probe (FDA Code: EXX / 876.4730)

• 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.

• Non-Self-Retaining Retractor (FDA Code: FGN / 876.4730)

• Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF / 880.6025) An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• Non-Surgical Tongue Depressor (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.

• One-Piece Scalpel (FDA Code: GDX / 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.

• Operating-Room Electrical Table (FDA Code: GDC / 878.4960) Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

• Operating-Room Table and Attachments (FDA Code: BWN / 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.

• Ophthalmic Caliper (FDA Code: HOE / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

• Ophthalmic Forceps (FDA Code: HNR / 886.4350)

• Ophthalmic Headband Mirror (FDA Code: HKF / 886.1500) A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye.

• Ophthalmic Retractor (FDA Code: HNI / 886.4350)

• Ophthalmic Speculum (FDA Code: HNC / 886.4350)

• Ophthalmic Suture Scissors (FDA Code: HNF / 886.4350)

• Ophthalmic Suturring Needle (FDA Code: HNM / 886.4350)

• 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 Cutting Instrument (FDA Code: HTZ / 878.4800)

• Orthopedic Elevator (FDA Code: HTE / 878.4800)

• Orthopedic Knife (FDA Code: HTS / 888.4540)

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

• Orthopedic Needle Holder (FDA Code: HXK / 888.4540)

• Orthopedic Osteotome (FDA Code: HWM / 878.4800)

• Otoscopes (FDA Code: ERA / 874.4770) An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

• Passer (FDA Code: HWQ / 888.4540)

• Patellofemorotibial Knee Prosthesis (FDA Code: MBH / 888.3565) A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

• Penile Clamp (FDA Code: FHA / 876.5160) A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.

• Percussor, Vibrator (FDA Code: GWZ / 882.1700) A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations.

• Periodontal Probes

• Physical/Chemical Sterilization Process Indicator (FDA Code: JOJ / 880.2800) A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

• Pin Surgical Driver (FDA Code: GFC / 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.

• Pinwheel (FDA Code: GWY / 882.1750) A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.

• 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 Operating Room Table (FDA Code: FWW / 878.4960)

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

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

• Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR / 878.5020) Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

• Polydioxanone Absorbable Surgical Suture (FDA Code: NEW / 878.4840) An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

• Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT / 878.5000) Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

• Polyglycolic Acid Synthetic Absorbable Suture (FDA Code: GAM / 878.4493) An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percentl-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. "Monograph for Absorbable Surgical Sutures;" it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

• Polymeric Surgical Mesh (FDA Code: FTL / 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.

• Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW / 878.5010) Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

• Powered Rongeur (FDA Code: HAD / 882.4845) A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.

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

• Pressure Infusor for I.V. Bags (FDA Code: KZD / 880.5420) A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.

• Probes (FDA Code: HXB / 888.4540)

• Probes (FDA Code: HXB / 888.4540)