Profile: Landen Tools Inc. specializes in producing custom medical and beauty tools. Our medical products include anesthesia instruments, diagnostic instruments, forceps and general instruments. We offer medical instruments, which comprise of bone clamps, cannula clamps, cardiovascular surgical saw blades, curettes, differential gas pressure transducers, disconnect forceps, disposable medical scissors and ear scissors. We also provide episiotomy scissors, forceps, general surgical scissors, nasal scissors, uterine clamps, uterine curettes, surgical retractors and orthopedic elevators.
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• Nasal Scissors Straight (FDA Code: KBD / 874.4420) |
• Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• 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-Powered Rectal Probe (FDA Code: EXX / 876.4730) |
• Non-Sterile Ent Wire Closure Forceps (FDA Code: NNQ / 874.3540) A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise. |
• Non-Sterile Ent Wire Cutting Scissors (FDA Code: NNU / 874.3540) |
• 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. |
• Nose Clips (FDA Code: BXJ / 868.6225) A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures. |
• Nuclear Uptake Probe (FDA Code: IZD / 892.1320) A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |
• Ophthalmic Curette (FDA Code: HNZ / 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 Muscle Clamp (FDA Code: HOB / 886.4350) |
• Ophthalmic Spatula (FDA Code: HND / 886.4350) |
• Orthopedic Elevator (FDA Code: HTE / 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. |
• Orthopedic Needle Holder (FDA Code: HXK / 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 Spatula (FDA Code: HXR / 878.4800) |
• Ossicle Holding Clamp (FDA Code: JYF / 874.4420) |
• 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. |
• Periodontal Probes |
• Powered Heating Unit (FDA Code: IRQ / 890.5950) A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature. |
• Probes (FDA Code: HXB / 888.4540) |
• Probes (FDA Code: HXB / 888.4540) |
• Salpingeal Curette (FDA Code: KBK / 874.4420) |
• Scalpel Blade (FDA Code: GES / 878.4800) |
• Scalpel Handle (FDA Code: GDZ / 878.4800) |
• Staphylococcus Aureus Dna-Probe (FDA Code: MCS / 866.3700) |
• Sterile ENT Wire Closure Forceps (FDA Code: JXX / 874.3540) |
• Sterile ENT Wire Cutting Scissors (FDA Code: JYA / 874.3540) |
• Strep Pneumoniae Dna-Probe (FDA Code: MCT / 866.3740) |
• Streptococcal DNA-Probe Reagent (FDA Code: MDK / 866.3740) |
• Surgical Curette (FDA Code: FZS / 878.4800) |
• Surgical Cutter (FDA Code: FZT / 878.4800) |
• Surgical Metal Tongue Depressor (FDA Code: KBL / 874.4420) |
• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540) |
• Surgical Retractor (FDA Code: GAD / 878.4800) |
• Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
• Tongue Depressors (FDA Code: FMA / 880.6230) |
• Tonsil Dissector (FDA Code: KBM / 874.4420) |
• Trabeculotomy Probes (FDA Code: HNK / 886.4350) |
• Trichomonas Vaginalis Dna Probe (FDA Code: MJK / 866.2660) A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease. |
• Tube Introduction Forceps (FDA Code: BWB / 868.5780) Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea. |
• 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. |
• Tweezer Type High-Frequency Epilator (FDA Code: KCX / 878.5360) The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy. |
• 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: |
• 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: |
• Wire Holding Forceps (FDA Code: HYA / 878.4800) |
• Yeast Dna Probe (FDA Code: MLA / 866.2660) |