BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STRYKER MANUFACTURING KALAMAZOO

    Reg #: 3007997036 · FEI: 3007997036 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    107
    Establishment Types
    1
    Classifications
    26

    Registration Details

    Registration Name
    STRYKER MANUFACTURING KALAMAZOO
    Registration Number
    3007997036
    FEI Number
    3007997036
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6201 South Sprinkle Road
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Accessory, Surgical Apparel LYU
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Apparatus, Exhaust, Surgical FYD
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Driver, Wire, And Bone Drill, Manual DZJ
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Drill, Bone, Powered DZI
    Probe, Radiofrequency Lesion GXI
    Generator, Lesion, Radiofrequency GXD
    Mixer, Cement, For Clinical Use JDZ
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Motor, Surgical Instrument, Ac-Powered GEY
    Camera, Cine, Endoscopic, Without Audio FWL
    Motor, Drill, Pneumatic HBB
    Helmet, Surgical FXZ
    Instrument, Ultrasonic Surgical LFL
    Unit, Operative Dental EIA
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Motor, Drill, Electric HBC
    Orthopedic Stereotaxic Instrument OLO
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Thoracolumbosacral Pedicle Screw System NKB
    Tourniquet, Pneumatic KCY
    Battery, Replacement, Rechargeable MOQ
    Lavage, Jet FQH
    Bur, Surgical, General & Plastic Surgery GFF

    Proprietary Names

    SWEAT BANDS 24/PKG SWEAT BANDS 36/PKG FLYTE BATTERIES FLYTE CHARGER Pi Drive 2 Motor Pi Drive 2 Plus Motor Monopolar Return Electrode Cable MIXER ACM PCD MIXEVAC CEMENT MIXERS AND KITS REVOLUTION AUTOPLEX AEQUALIS PERFORM 4102-452 w/no feet on bottom sterilization case System 4000 mini sterilization case Battery Powered ScrewDriver II Battery Pack for VariSpeed Stryker VariSpeed BATTERY POWERED SCREWDRIVER II HUMMER IV 7.5MM Round FoCESS HD Wireless Camera System Stryker Maestro System FLYTE HELMETS T5 HELMETS Stryker Aria Pneumatic System STRYKER DRILL CORE System Stryker Maestro Air Motor Stryker Maestro Air Motor with Handswitch TPS Console TPS Standard Attachment Brush TPS Micro Drill/Elite Attachment Brush TPS Unidirectional Footswitch Stryker(R) Consolidated Operating Room Equipment (CORE) System 4cm Angled Irrigation Clip 4cm Straight Irrigation Clip RemB Micro Drill NexFix IMN™ Instruments drill Made-To-Order Tornier Simpliciti Shoulder System MaxTorque Compression Staple System Latitude EV Aequalis Perform+ CalcLock MaxLock Tornier Perform Humeral System Tornier Perform Reversed Pangea Torque Limiting Adapter Aequalis Flex Revive Tornier Extraction Tornier Humeral Nail Pangea Platform Hoffmann LRF SMOKE EVACUATION TUBING/WAND NEPTUNE WASTE MGMT(SMOKE EVACUATOR) Neptune 2 Rover (120V) Neptune 2 Single-Port Manifold Smoke Evacuator ULPA Filter Neptune 2 4-Port Manifold Neptune 2 Specimen Collection 4-Port Manifold Neptune 2 Docking Station (120V) Neptune 2 Docking Station (230V) Fluid Suction HEPA Filter Neptune 2 Rover (230V) Smoke (Evacuator) Tubing, 3/8 inch x 10 feet Smoke (Evacuator) Tubing, 7/8 inch x 10 feet Neptune Smart Docking Station (120V) E-TYPE SPEED REDUCER CONTRA ANGLE Stryker CORE System Stryker Smart Pump INTERPULSE SURGILAV Pi Drive Plus Motor Pi Drive Extender 0485-840-000 - XL Round Diamond Bur, 4 mm 0485-860-000 - XL Round Diamond Bur, 5.5 mm Dual Edge Shaver Blade 4mm Dual Edge Shaver Blade 5.5mm Tomcat HC Shaver Blade 4mm Aggressive Max Shaver Blade 3.5mm Smooth Bite Shaver Blade 3.5mm Dual Edge Shaver Blade 3.5mm Bursector 5.5 mm Bursector 4 mm MIS 16 cm Straight Nose Tube Non-Footed Attachment 8cm Non-Footed Attachment 9cm Footed Attachment 25mm MIS 13 cm Curved Nose Tube Footed Attachment 12mm Rotating Footed Attachment 16mm Rotating Footed Attachment 12mm MIS 13 cm Angled Nose Tube Rotating Footed Attachment 25mm MIS 13 cm Straight Hooded Nose Tube MIS 13 cm Straight Nose Tube MIS 16 cm Angled Nose Tube MIS 16 cm Curved Nose Tube MIS 13 cm Modified Curved Nose Tube Footed Attachment 16mm MIS 16 cm Straight Hooded Nose Tube

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)