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Data / Medical devices / United States / Steris Corporation

Steris Corporation: FDA-registered device maker in Montgomery, AL, United States, 15 510(k) clearances

Steris Corporation is registered with the FDA (registration 1043572) in Montgomery, AL, United States. It lists 40 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 13, 2020. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Steris Corporation
FDA registration number
1043572
Address
2720 Gunter Park Drive East, Montgomery, AL, United States, 36109
Owner or operator
STERIS Corporation (10078069)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
October 9, 2020
Registered through
2027
Brand names listed
4085 General Surgical Table (MG-CFE), 4095 General Surgical Table (MG-MF), 4195 General Surgical Table (MG-MF), 5085 General Surgical Table (MG-CFE), 5085 Harmony Surgical Table (MG-CFE), 5085 Harmony Table Pads (MG-RR), 5085 SRT Transducer Arm (MG-MF), 5085 SRT Upgrade Kit (MG-MF) and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Exhaust, SurgicalFYD2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Apparatus, Traction, Non-PoweredHST1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bassinet, HospitalNZG2Manufactureraccessdata.fda.gov
Board, Arm (With Cover), Non-SterileNOD1Contract manufactureraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Chair, Surgical, Ac-PoweredGBB1Repackager or relabeleraccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Manufactureraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Complaint file establishment, Manufactureraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Repackager or relabeleraccessdata.fda.gov
Halter, Head, TractionHSS1Repackager or relabeleraccessdata.fda.gov
Headrest, NeurosurgicalHBM1Manufacturer, Specification developeraccessdata.fda.gov
Hook, BoneKIK1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Complaint file establishment, Specification developeraccessdata.fda.gov
Light, Surgical, Ceiling MountedFSY2Complaint file establishment, Manufactureraccessdata.fda.gov
Light, Surgical, FiberopticFST2Complaint file establishmentaccessdata.fda.gov
Light, Surgical, Floor StandingFSS2Complaint file establishment, Manufactureraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Manufacturer, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Protector, Skin PressureFMP1Repackager or relabeleraccessdata.fda.gov
Restraint, ProtectiveFMQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Screen, Leaded, Operator Radiation ProtectorEAK1Repackager or relabeleraccessdata.fda.gov
StirrupsEYD1Repackager or relabeleraccessdata.fda.gov
Support, Patient PositionCCX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Surgical Table CushionLWG1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Thermal RegulatingDWJ2Manufactureraccessdata.fda.gov
Table And Attachments, Operating-RoomBWN1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Table, Operating-Room, Ac-PoweredFQO1Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developeraccessdata.fda.gov
Table, Operating-Room, ElectricalGDC1Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Table, Operating-Room, PneumaticFWW1Complaint file establishmentaccessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Ac-PoweredJEA1Manufactureraccessdata.fda.gov
Table, Surgical With Orthopedic Accessories, ManualJEB1Complaint file establishment, Manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Complaint file establishment, Specification developeraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Complaint file establishmentaccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Complaint file establishmentaccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Complaint file establishmentaccessdata.fda.gov
Warmer, Thermal, Infusion FluidLGZ2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 13, 2020K200446STERIS Patient Warming SystemDWJSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
March 3, 2014K131402VISICLEAR SMOKE EVACUATION SYSTEMFYDSubstantially EquivalentBuffalo Filter Co., Inc.accessdata.fda.gov
July 29, 2011K111870AMSCO WARMING CABINETLGZSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
June 3, 2011K110769AMSCO WARMING CABINETLGZSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
August 12, 2010K100551ORLOCATE SYSTEM MODEL ORL 100LWHSubstantially EquivalentHaldor Advanced Technologies, Ltd.accessdata.fda.gov
March 17, 2010K100395HARMONY VLED SURGICAL LIGHTNING SYSTEMFSTSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
December 18, 2009K092823AMSCO WARMING CABINETLGZSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
March 20, 2009K090136STERIS CMAX XLT SURGICAL TABLEFQOSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
October 5, 2007K072072HARMONY LED-1 SURGICAL LIGHTING SYSTEMFSYSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
June 27, 1997K971307AMSCO SURGICAL TABLEFQOSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
November 3, 1993K930041VICROSAFE 6 AND VICROSAFE 12FYDSubstantially EquivalentBuffalo Filter Co., Inc.accessdata.fda.gov
September 13, 1993K924732PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEMFYDSubstantially EquivalentBuffalo Filter Co., Inc.accessdata.fda.gov
June 22, 1993K930493QUANTUM 3080 SURGICAL TABLEFQOSubstantially EquivalentAmerican Sterilizer Co.accessdata.fda.gov
March 6, 1991K905816ORTHOVISION TABLEJEBSubstantially EquivalentAmerican Sterilizer Co.accessdata.fda.gov
July 25, 1988K882660GENERAL SURGICAL TABLE AND ACCESSORIESFQOSubstantially EquivalentAmerican Sterilizer Co.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
February 6, 200737349Not yet classifiedTerminatedCmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USAA variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff.accessdata.fda.gov
June 22, 200635737Not yet classifiedTerminatedSteris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSSSmoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire.accessdata.fda.gov

Compare with other makers

Updated June 13, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.