Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1043572

FEI Number

1043572

Entity Name

STERIS CORPORATION

City/State/Country

MONTGOMERY, AL, US

Establishment Address

2720 GUNTER PARK DRIVE EAST, MONTGOMERY, AL 36109, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STERIS Corporation (Owner Number: 10078069)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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) HarmonyAIR Smoke Evacuation System (QS0018) (MG-RR) 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) ORLocate Vaginal Packing (MG-RR) ORLocate Towel (MG-RR) ORLocate Gauze (MG-RR) ORLocate Sponge (MG-RR) 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) IDSS-SLC (version 7 and 8) (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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2020-11-18
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2020-11-18
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2021-01-25
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2020-11-18
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2020-11-18
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2021-03-28
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2020-11-18
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2020-11-18
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2020-11-18
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-11-18
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2024-06-23
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2020-11-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-03-29
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2020-10-13
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2020-10-29
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2020-10-10
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2020-11-18
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	2021-03-28
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2020-11-18
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2020-11-18
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2020-11-18
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2021-03-28
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2020-11-18
EYD	Stirrups	Gastroenterology, Urology	Class 1	876.4890	2022-12-18
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2020-11-18
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2020-11-18
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2020-11-18
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2020-11-18
JEB	Table, Surgical With Orthopedic Accessories, Manual	General, Plastic Surgery	Class 1	878.4950	2020-11-18
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2025-03-09
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2020-11-18
FWW	Table, Operating-Room, Pneumatic	General, Plastic Surgery	Class 1	878.4960	2020-11-18
HBM	Headrest, Neurosurgical	Neurology	Class 1	882.4440	2020-11-18
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2020-10-22
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2020-11-18
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2020-10-29
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2020-11-18
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-03-09
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2020-11-18
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2020-11-18
EAK	Screen, Leaded, Operator Radiation Protector	Radiology	Class 1	892.6500	2021-07-07
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2020-10-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
Z-0040-2017	Trumpf Medical Systems, Inc.	1	Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Z-0041-2017	Trumpf Medical Systems, Inc.	1	Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0042-2017	Trumpf Medical Systems, Inc.	1	Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0043-2017	Trumpf Medical Systems, Inc.	1	Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043572. Last updated year: 2026. Please use registration number 1043572 when referencing this establishment in official correspondence.