BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BOSS INSTRUMENTS, LTD.

    Reg #: 1056350 · FEI: 1000140363 · Expires 2026
    View on FDA
    Products
    160
    Proprietary Names
    26
    Establishment Types
    3
    Classifications
    160

    Registration Details

    Registration Name
    BOSS INSTRUMENTS, LTD.
    Registration Number
    1056350
    FEI Number
    1000140363
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    104 Sommerfield Drive
    City
    Gordonsville
    State
    VA
    ZIP
    22942
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081651

    Owner / Operator

    Firm Name
    BOSS INSTRUMENTS, LTD.
    Operator Number
    9005081
    Address
    104 Sommerfield Drive, --
    City
    Gordonsville
    State
    VA
    Postal Code
    22942
    Country
    US
    Correspondent
    John C Ryall

    Products

    Device Name Product Code
    Saw, Manual And Accessories GDR
    Curette, Ophthalmic HNZ
    Forceps, Obstetrical HDA
    Holder, Needle; Orthopedic HXK
    Forceps, Rongeur, Surgical EMH
    Rongeur, Manual HAE
    Spud, Ophthalmic HNA
    Punch, Antrum KAW
    Dilator, Tracheal KCG
    Elevator, Surgical, Dental EMJ
    Retractor, Ent KAL
    Curette, Surgical, Dental EMK
    Bit, Drill HTW
    Retractor, Self-Retaining, For Neurosurgery GZT
    Cutter, Wire HXZ
    Mirror, Mouth EAX
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Curette, Endodontic EKT
    Instrument, Ent Manual Surgical LRC
    Pliers, Surgical HTC
    Hemostat HRQ
    Chisel, Bone, Surgical EML
    Clamp HXD
    Rasp, Ear JYY
    Spatula, Ophthalmic HND
    Probe, Ent KAK
    Punch, Skull GXJ
    Awl HWJ
    Rasp, Surgical, General & Plastic Surgery GAC
    Applier, Surgical, Clip GDO
    Curette HTF
    Clamp, Vascular DXC
    Fork HXE
    Forceps, Biopsy, Gynecological HFB
    Laparoscope, General & Plastic Surgery GCJ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Instruments, Dental Hand DZN
    Dilator, Cervical, Fixed Size HDQ
    Holder, Needle, Gastroenterologic FHQ
    Retractor, Ophthalmic HNI
    Tamp HXG
    Cannula, Surgical, General & Plastic Surgery GEA
    Hook, Ophthalmic HNQ
    Cannula, Ophthalmic HMX
    File, Bone, Surgical EMI
    Tape, Measuring, Rulers And Calipers FTY
    Ring, Ophthalmic (Flieringa) HNH
    Curette, Ear JYG
    Elevator, Ent KAD
    Forceps, Ophthalmic HNR
    Curette, Surgical, General Use FZS
    Irrigator, Sinus KAR
    Loop, Wire JYQ
    Tube, Ear Suction JZF
    Dilator, Vessel, Surgical DWP
    Knife, Surgical EMF
    Knife, Ear JYO
    Countersink HWW
    Probe, Lachrymal HNL
    Chisel, Middle-Ear JYE
    Crimper, Wire, Ent, Sterile JXT
    Probe, Trabeculotomy HNK
    Needle, Ophthalmic Suturing HNM
    Handle, Scalpel GDZ
    Hook, Bone KIK
    Trephine, Manual, Ophthalmic HRH
    Snare, Tonsil KBZ
    Hook, Surgical, General & Plastic Surgery GDG
    Probe HXB
    Rasp, Nasal KBA
    Depressor, Orbital HNX
    Rongeur HTX
    Mirror, Ent KAI
    Speculum, Rectal FFQ
    Specula, Ophthalmic HNC
    Punch, Surgical LRY
    Screwdriver HXX
    Tray, Surgical LRP
    Dilator, Lachrymal HNW
    Cystotome HNY
    Scissors, General, Surgical LRW
    Instrument, Surgical, Non-Powered HAO
    Knife, Amputation GDN
    Chisel (Osteotome) KDG
    Extractor HWB
    Retractor, Self-Retaining FFO
    Chisel, Surgical, Manual FZO
    Catheter And Tip, Suction JOL
    Orthopedic Manual Surgical Instrument LXH
    Gauge, Depth HTJ
    Instrument, Ligature Passing And Knot Tying HCF
    Guide, Surgical, Instrument FZX
    Clamp, Non-Electrical FFN
    Clamp, Uterine HGC
    Speculum, Vaginal, Metal HDF
    Caliper, Ophthalmic HOE
    Spatula, Surgical, General & Plastic Surgery GAF
    Instrument, Manual, Surgical, General Use MDM
    Bougie, Urological FAX
    Saw HSO
    Needle, Suturing, Reusable GDL
    Retractor, Vaginal HDL
    Forceps, Tooth Extractor, Surgical EMG
    Carrier, Ligature GEJ
    Tray, Surgical, Instrument FSM
    Passer HWQ
    Punch, Ent KTF
    Syringe, Ent KCP
    Retractor GAD
    Needle, Aspiration And Injection, Reusable GDM
    Speculum, Non-Illuminated FXE
    Retractor, All Types EIG
    Mobilizer, Ent KAJ
    Clamp, Surgical, General & Plastic Surgery GDJ
    Trocar, Ent KTE
    Impactor HWA
    Osteotome HWM
    Forceps, Ent KAE
    Rod, Measuring Ear JYZ
    Hook, Microsurgical Ear JYL
    Scissors, Ophthalmic HNF
    Forceps, Tube Introduction BWB
    Elevator, Surgical, General & Plastic Surgery GEG
    Instruments, Surgical, Cardiovascular DWS
    Knife, Ent KTG
    Cannula, Ear JYC
    Dissector, Surgical, General & Plastic Surgery GDI
    Snare, Ear JZD
    Sound, Uterine HHM
    Excavator, Ear JYH
    Chisel, Nasal KAN
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Gag, Mouth KBN
    Gouge, Surgical, General & Plastic Surgery GDH
    Trephine HWK
    Pick, Microsurgical Ear JYT
    Hook, Tracheal KCH
    Instrument, Microsurgical GZX
    Instrument, Cast Application/Removal, Manual LGG
    Tourniquet, Gastro-Urology EYR
    Instrument, Bending Or Contouring HXP
    Crimper, Wire, Ent, Non-Sterile NNN
    Osteotome, Manual GFI
    Specula Accessories FXG
    Forceps, General & Plastic Surgery GEN
    Forceps, Surgical, Gynecological HCZ
    Retractor, Fiberoptic FDG
    Snare, Nasal KBE
    Punch, Corneo-Scleral HNJ
    Speculum, Ent EPY
    Curette, Uterine HCY
    Knife, Ophthalmic HNN
    Source, Carrier, Fiberoptic Light EQH
    Mallet, Surgical, General & Plastic Surgery GFJ
    Hemostat, Surgical EMD
    Scissors, Orthopedic, Surgical HRR
    Stripper, Surgical HRT
    Twister, Wire HXS
    Tube, Tonsil Suction KCB
    Chisel, Osteotome, Surgical EMM

    Proprietary Names

    BOSS Boss Obstetrical Forceps dental rongeur Tracheal Dilator Boss Mirror Endodontic Curette bone chisel Curette Lacrimal Probe Bone Hook dermal punch Amputation Knife Osteotome uterine clamp BOS Reverdin Needle General Instrument Tray Boss Dental Retractors surgical clamp ENT Knife Uterine Sound tracheal hook wire crimper LightMat, VersaLight Nasal Snare Boss Fiber Optic Cable

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device