Profile: Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products.

NYSE:BOL (SEC Filings)

FDA Registration Number: 1032500

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• AC-Powered Keratome (FDA Code: HNO / 886.4370) A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

• AC-Powered Radiofrequency Cautery Apparatus (FDA Code: HQR / 886.4100) A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

• AC-Powered Vitreous Aspiration and Cutting Instrument (FDA Code: HQE / 886.4150) A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

• Accommodative Intraocular Lens (FDA Code: NAA / 886.3600) An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

• Adenoid Curettes (FDA Code: KBJ / 874.4420)

• Adenotomes (FDA Code: KBH / 874.4420)

• Antrum Perforator (FDA Code: KAT / 874.4420)

• Automatic Surgical Stapler (FDA Code: GAG / 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.

• Balloon Type Catheter (FDA Code: GBA / 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.

• Bone Fixation Plate (FDA Code: HRS / 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.

• Citrobacter Spp. Bethesda - Ballerup Polyvalent Antisera (FDA Code: GTF / 866.3125)

• Collagen Corneal Shield (FDA Code: MOE / 886.4750) An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

• Compression Instrument (FDA Code: HWN / 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.

• Connecting Flexible Aspirating Tube (FDA Code: BYY / 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).

• Contact (Orthokeratology) Lens (FDA Code: MUW / 886.5916) A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

• Contact Extended Wear Lens (FDA Code: MWL / 886.5916)

• Contact Lens (FDA Code: HQD / 886.5916)

• Contact Lens (Disposable) (FDA Code: MVN / 886.5925) A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

• Contact Lens Case, Container (FDA Code: LRX / 886.5928) A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

• Corneal Storage Media (FDA Code: LYX)

• Corneo-Scleral Punch (FDA Code: HNJ / 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.

• Cystotome (FDA Code: HNY / 886.4350)

• Daily Wear Soft Contact Lenses (FDA Code: LPL / 886.5925)

• Diagnostic/Surgical Loupe (FDA Code: FSP / 878.4800)

• Disposable Medical Scissors (FDA Code: JOK / 880.6820) Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical 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 Suture Needle (FDA Code: GAB / 878.4800)

• Ear Curette (FDA Code: JYG / 874.4420)

• Ear Excavator (FDA Code: JYH / 874.4420)

• Ear Knife (FDA Code: JYO / 874.4420)

• Ear Rasp (FDA Code: JYY / 874.4420)

• Ear Scissors (FDA Code: JZB / 874.4420)

• Ear Snare (FDA Code: JZD / 874.4420)

• Ear Speculum (FDA Code: EPY / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Ear Suction Tube (FDA Code: JZF / 874.4420)

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Endoilluminator (FDA Code: MPA / 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.

• ENT Applicator (FDA Code: KCJ / 874.5220) An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

• ENT Elevator (FDA Code: KAD / 874.4420)

• ENT Esophageal Bougie (FDA Code: KCD / 874.4420)

• ENT Forceps (FDA Code: KAE / 874.4420)

• ENT Irrigation Syringe (FDA Code: KCP / 874.5220)

• ENT Knife (FDA Code: KTG / 874.4420)

• ENT Mirror (FDA Code: KAI / 874.4420)

• ENT Mobilizer (FDA Code: KAJ / 874.4420)

• ENT Probe (FDA Code: KAK / 874.4420)

• ENT Retractor (FDA Code: KAL / 874.4420)

• ENT Speculum Holder (FDA Code: KAG / 878.1800)

• ENT Syringe (FDA Code: KCP / 874.5220)

• ENT Tracheal Hook (FDA Code: KCH / 874.4420)