BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERIS CORPORATION

    Reg #: 1043572 · FEI: 1043572 · Expires 2026
    View on FDA
    Products
    40
    Proprietary Names
    230
    Establishment Types
    6
    Classifications
    40

    Registration Details

    Registration Name
    STERIS CORPORATION
    Registration Number
    1043572
    FEI Number
    1043572
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2720 GUNTER PARK DRIVE EAST
    City
    MONTGOMERY
    State
    AL
    ZIP
    36109
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090136

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10078069
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Tubing, Pressure And Accessories BYX
    Tubing, Noninvasive GAZ
    Operating Room Accessories Table Tray FWZ
    Table, Operating-Room, Ac-Powered FQO
    Apparatus, Traction, Non-Powered HST
    Table, Surgical With Orthopedic Accessories, Ac-Powered JEA
    Apparatus, Exhaust, Surgical FYD
    Tray, Surgical LRP
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Light, Surgical, Floor Standing FSS
    Orthopedic Manual Surgical Instrument LXH
    Device, Medical Examination, Ac Powered KZF
    Table And Attachments, Operating-Room BWN
    Light, Surgical, Accessories FTA
    Light, Surgical, Ceiling Mounted FSY
    Halter, Head, Traction HSS
    Chair, Surgical, Ac-Powered GBB
    Hook, Bone KIK
    Support, Patient Position CCX
    Warmer, Thermal, Infusion Fluid LGZ
    Stirrups EYD
    Table, Operating-Room, Electrical GDC
    Camera, Surgical And Accessories KQM
    Table, Surgical With Orthopedic Accessories, Manual JEB
    Counter, Sponge, Surgical LWH
    Table, Operating-Room, Pneumatic FWW
    Headrest, Neurosurgical HBM
    Instrument, Manual, Surgical, General Use MDM
    Restraint, Protective FMQ
    Surgical Table Cushion LWG
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Gauze / Sponge,Nonresorbable For External Use NAB
    System, Thermal Regulating DWJ
    Screen, Leaded, Operator Radiation Protector EAK
    Drape, Surgical, Exempt PUI
    Protector, Skin Pressure FMP
    Bassinet, Hospital NZG
    Light, Surgical, Fiberoptic FST
    Device, Transfer, Patient, Manual FMR
    Board, Arm (With Cover), Non-Sterile NOD

    Proprietary Names

    HarmonyCARE Critical Care Boom (MG-CFE) HarmonyAIR Smoke Evacuator Filter Fluid Trap (QS0027) (MG-CFE) HarmonyAIR Smoke Evacuator Tubing (QS0023, QS0024, QS0025) (MG-CFE) Foot Extensions (MG-MF) Surgical Drape Support (MG-MF) Table Clamp (MG-MF) Clark Socket (MG-MF) Table Clamp (BF788, TAB841) (MG-SD, LC- FE, PM-CM) 5085 SRT Transducer Arm (MG-MF) 5085SRT Surgical Table (MG-MF) 5085 SRT Upgrade Kit (MG-MF) Accessory Packages for 5085 SRT Surgical Tables (MG-MF) AMSCO 4085 General Surgical Table Traction Boot (MG-MF) OT1000 Traction Boot Foam Pads with Straps (MG-RR) Traction Boot Insert (MG-RR) OT1000 Series Orthopedic Surgical Tables (MG-MF) Orthopedic Table Accessory Packages (MG-MF) Accessory Packaages for 3085 Surgical Table (MG-MF) AMSCO 3085-SP Surgical Table (MG-CFE) AMSCO 3085-R Surgical Table (MG-CFE) HarmonyAIR Smoke Evacuation System (QS0018) (MG-RR) Non-sterile Light Handle Cover Tray (MG-SD) ORLocate Sponge (MG-RR) ORLocate Towel (MG-RR) ORLocate Gauze (MG-RR) ORLocate Vaginal Packing (MG-RR) HarmonyAIR A-Series Mobile Surgical Light (MG-MF) HarmonyAIR M5 Mobile Surgical Light (MG-CFE) HarmonyAIR G5 Mobile Surgical Light (LG0055) (MG-CFE) HarmonyAIR G5 Mobile Surgical Light (LG0056) (MG-MF) Orthopedic Extension Abductor Bar Assembly (MG-MF) Skeletal Traction Bow with Block (MG-RR) Traction Device (MG-MF) Arthroscopy Knee Holder (MG-MF) Femur Positioner Drive (MG-MF) Femur Positioner Assembly (MG-MF) L-Shaped Traction Extension (MG-MF) Femur Drive S Bracket Attachment (MG-MF) Orthopedic Extension (MG-MF) Hip Rest, Spica and Sacral for Orthopedic Tables (MG-MF) Femur Drive Table Attachment - Plunger (MG-MF) Femur Positioner Rail (MG-MF) Hexalux Mobile Stand (MG-MF) AMSCO LD202 Wall Controller (MG-CFE) Hexalux Examination Light (MG-MF) AMSCO LD202 In-Ceiling Lighting System (MG-CFE) LED202 In-Ceiling Dual Lighting System (MG-MF) LED202 In-Ceiling Single Lighting System (MG-MF) Lithotomy Legholders - Adult (Pair) (MG-MF) Split Leg Positioner (MG-RR) Shoulder Table (MG-MF) Transducer Support Holder (MG-MF) Table Extenders with/without Pads (MG-MF) Surgical Tabletop Mushroom Cap Conversion Kit (MG-MF) MIO Medical Device Organizer (EN-SD) Arm Supports (MG-RR, MF) Table Side Rails (MG-MF) Ether Screen (MG-MF) Shoulder Table and Accessory Package (MG-RR, MF) ARCH Orthopedic Leg Positioner (MG-RR) CMAX X-ray Table Side Rails (MG-SD, LC-FE, PM-CM) Tibia Counter Traction Assembly (MG-MF) HexaVue Focus Integration System-Surgical Light Control (RM-MF) Hexalux Sterilizable Light Handle (MG-MF) Harmony iQ 3600-SLC (RM-CFE) Sterile Handle Camera Cover (MG-SD, RO-RR) Sterile Light Handle Cover (MG-SD, RO-RR) IDSS-SLC (version 7 and 8) (RM-CFE) Universal Light Handle Cover (MG-SD, RO-RR) Harmony iQ 2400-SLC (RM-CFE) Harmony iQ 2800-SLC (RM-CFE) HexaVue IP In-Light Control Systems (RM-MF) HarmonyAIR M-Series Lighting System (MG-CFE) HarmonyAIR E-Series Lighting System (MG-CFE) HarmonyAIR G-Series Lighting System (MG-MF) AMSCO HarmonyAIR G-Series Lighting System (MG-MF) HarmonyAIR A-Series Lighting System (MG-MF) ALYON Surgical Lighting System (MG-MF) Shoulder Table Chair Cups (MG-RR) Shoulder Chair (BF594) (MG-RR) Shoulder Beach Chair (MG-RR) HarmonyAIR Smoke Evacuator Remote Switch Activator (QS0028) (MG-CFE) Femur Hook (MG-MF) Femur Hook Assembly (MG-MF) Femur Hook and Rail Package (MG-MF) Andrews Frame Adaptor (MG-MF) Sacral Rest (MG-RR) Perineal Posts with/without Pads (MG-RR) Hip Spica and Rest (MG-MF) AMSCO Warming Cabinet PowerLift Freedom Stirrups (MG-RR) PowerLift Plus Stirrups (MG-RR) HarmonyAIR Smoke Evacuator Filter (QS0022) (MG-CFE) AMSCO Pass-Thru Warming Cabinet ShroudGuard (MG-RR) Hand Control for SurgiGraphic 1027 Surgical Table (MG-CFE) SurgiGraphic 6000 FB Image Guided Surgical Table (MG-CFE) SurgiGraphic 6000 Surgical Table (MG-CFE) Catheter Extension (TAB800KT) (MG-SD, LC-FE, PM-CM) SurgiGraphic Table Accessory Package (MG-CFE) CMAX XRAY NA Surgical Table (MG-MF) Remote Control for CMAX XRAY Table (BF713, V543715996) (MG-SD, LC-FE, PM-CM) CMAX XRAY NA JOYSTICK (MG-SD, LC-FE, PM-CM) CMAX XRAY Surgical Table (MG-MF) CMAX X-ray Table Side Rails (BF787, TAB830) (MG-SD, LC-FE, PM-CM) Catheter Extension (TA00002) (MG-MF) XLED HD Camera Orthovision Orthopedic Fracture Table (MG-CFE) Orthovision Orthopedic Fracture Table Accessory Packages (MG-MF) ORLocate Sponge System AMSCO 3080 RL General Surgical Table (MG-CFE) AMSCO 3080 SP General Surgical Table (MG-CFE) Compensated single articulation headrest (HEAD02) (MG-SD, LC-FE, PM-CM) Horizontal Attachment 1800 (MG-MF) Dual Articulating Headrest (MG-MF) Eye-ENT-Neuro Headrest Adaptor (MG-MF) Frontal Sitting Attachment 1802 (MG-MF) Posterior Sitting Attachment 1801 (MG-MF) Horshoe Headrest Assembly (MG-MF) Cmax Xray Headrest Adaptor (MG-MF,SD, LC-FE, PM-CM) Sterilizable Aluminum Handle for Harmony and HarmonyAIR (MG-RR) Sterilzable Aluminum Handle with Sterile Surgeon Control (MG-RR) ROLL-A-SET NEEDLE/PIN HLD 50/BX NE1 (PC-RR) ROLL-A-SET FOAM ROLL 12/BX NE1 (PC-RR) ROLL-A-SET 10 POC 25/BX NH1 (PC-RR) Non-Sterile Disposable Light Handle (MG-RR) Plastic Handle (MG-RR) ROLL-A-SET 1 POC 100/BX NJ1 (PC-RR) ROLL-A-SET 200 POC ROLL 1/BX NG1 (PC-RR) Silicone Ring (MG-RR) Alyon Standard Light Handle (MG-MF) Body Restraints (MG-RR) Safety Straps (MG-MF) HLT Pads (MG-RR) Beach Chair Pads (MG-MF) Perineal Cutout Filler Piece (MG-MF) Surgical Table Pads (MG-MF, RR) Cmax Xray Mattress (MG-RR) Stretcher Pads (MG-MF) 5085 Harmony Table Pads (MG-RR) Armboard Pads (MG-MF) Birkova Table Pads (MG-MF) Elite Pads (MG-RR) Table Pad Accessory Packages (MG-MF) TLT Pads (MG-RR) Arm Hand Table Pads (MG-MF) Aquagel Pads (MG-RR) Kyra Medical Surgical Table Arm and Leg Pads (MG-CM) BOOST Head Positioner (EN-SD) Table Pads for CMAX XRAY NA Surgical Table (MG-RR) Oasis Pads (MG-RR) HarmonyAIR Smoke Evacuator Laparoscopic Tubing (QS0026) (MG-CFE) AMSCO 3080-RC General Surgical Table (MG-CFE) AMSCO 3080 General Surgical Table (MG-CFE) BF035 STERIS Patient Warming System OverBody Blanket BF030 STERIS Patient Warming System Pack BF033 STERIS Patient Warming System Complete Pad Set BF037 STERIS Patient Warming System 3-inch TLT Pad Heated BF032 STERIS Patient Warming System Controller rShield (MG-RR) VividImage 32" 4K Surgical display (RM-RR) VividImage 27" 4K Surgical Monitor (RM-CFE) G-Series HD Camera in Case (MG-MF) VividImage 31" 4K Surgical Monitor (RM-CFE) 58" Display Monitor (8MP) (RM-RR) 55" Vividimage W HD Wall Display (RM-RR) HexaVue IP In-Light Camera Control System (RM-MF) M-Series HD Camera (MG-MF) VividImage W 4K 65 4K Medical Wall Display (RM-RR) Vividimage W HD Wall Display (42") (RM-RR) Free 5 Camera System (RM-CFE) Harmony iQ 2800-SLC (RM-CFE) Vividimage D HD Surgical Display (27") (RM-RR) Harmony iQ 2400-SLC (RM-CFE) Harmony iQ 3600-SLC (RM-CFE) Vividimage T HD Surgical Display (RM-CFE) Vividimage W HD Wall Display 50-inch (RM-CFE) HexaVue Focus In-Light Camera Control System (RM-MF) Vividimage W HD Wall Display 65-inch (RM-RR) A-Series HD Camera (MG-MF) ORLocate Sterile Drapes (MG-RR) AMSCO Mid-Size Warming Cabinet Harmony LED Surgical Lighting System (MG-CFE) LED585 (MG-CFE) LED785 (MG-CFE) Perineal Post Pad - Disposable (NO001) (MG-RR) Bassinet Pad (MG-MF) 5085 General Surgical Table (MG-CFE) HarmonyAIR M-Series Suspension (MG-CFE) 5085 Harmony Surgical Table (MG-CFE) 4085 General Surgical Table (MG-CFE) HarmonyAIR A-Series Suspension (MG-MF) X-Ray Tops (MG-MF) Headrest Sections with or without Pads (MG-MF) Cone-Shaped Headrest with/without Pads (MG-MF) Hand and Foot Controllers for Surgical Tables (MG-RR) Bariatric Urology Package (MG-MF) Gastric Bypass Table Package (BF851) (MG-MF) X-Ray Cassette Tray with Handle (MG-MF) Table Extenders with Pads (MG-MF) Radiolucent Table Extenders (MG-MF) HarmonyAIR E-Series Suspension (MG-CFE) 5095 General Surgical Table (MG-MF) HarmonyAIR EMS (MG-MF) Short Featherweight Leg Section with Pads for 4085, 5085 and 5085SRT Tables (MG-MF) Leg Sections with/without Pads (MG-MF) HarmonyAIR Utility Hub (MG-MF) 4095 General Surgical Table (MG-MF) HarmonyAIR Monitor Carrier (MG-CFE) HarmonyAIR G-Series Suspension (MG-MF) Surgical Table Accessory Packages (MM-RR, MG-MF, RR) Morgan Pelvic Rest (MG-MF) Radial AV Fistula Board with Pad (MG-MF) HarmonyAIR EMS Shelf (MG-MF) Lateral Braces (MG-MF) Drain Pan (BF186) (MG-MF) Fluoroscent Table Extension (MG-MF) Imaging Table Extension (MG-MF) 7080 General Surgical Table (MG-MF) Cassette Tray and Film Holder (TAB733) (MG-SD, LC-FE, PM-CM) ALYON Suspension System (MG-RR) HarmonyAir Monitor Carrier Multibar Unit (MG-RR) HarmonyAir Monitor Carrier Multibar Retrofit Kit (MG-RR) vLED Surgical Lighting System (MG-CFE) Hana Table Cover Set, 3-piece (PRT9410) (MG-MF) Transfer Board (BF204, BF213, BF214) (MG-MF) Patient Transfer Extension Frame Cover for STERIS 3080, 3085 (SC3320PT9) (MG-MF) IA Extension Frame Cover - Orthographic II or Orthovision (SC35409) (MG-MF) Mid Central Surgical Table Arm Pads (MG-CM)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)