{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-19", "results": { "skip": 0, "limit": 1, "total": 36 } }, "results": [ { "proprietary_name": [ "Universal Rack - Cart Washer (FD372) (QB-MF)", "InnoWave STANDARD BASKET FOR PCF DROP+LOCK (MD-MF)", "3 Level base Rack for MIS, Ophtalmic or dental application (FD024) (QB-MF)", "Upper universal insert (FD80200) (QB-MF)", "Niagara SI Ultrasonic (MD-CFE)", "FOUR Level Manifold Rack for US TRAYS - Long (FD144) (QB-MF)", "Tray Rack without Hooks (CM55) (QB-MF)", "ORTHO BASKET FOR PCF DROP+LOCK (MD-MF)", "Standard Basket for MEDISAFE SI SA (IW1010) (MD-MF)", "4 Level Orthopetic Rack (FD79200) (QB-MF)", "Multi-function Rack for Large Items - Large (FD81800) (QB-MF)", "Three Level base Rack for MIS, Ophthalmic or dental application - Long (FD112) (QB-MF)", "5 Level Manifold Rack (FD75200) (QB-MF)", "Bedpan Rack wtihout Hooks (CM56) (QB-MF)", "AMSCO 2532 2 Level Rack Equal Space (FD038) (QB-MF)", "Container Rack (FD322) (QB-MF)", "Three Level Manifold Rack- Long (FD107) (QB-MF)", "ROBOTIC BASKET FOR PCF XI DROP+LOCK (MD-MF)", "Niagara Carrier MED1427 (MD-CFE)", "3 Level Manifold Rack - Large (FD81200) (QB-MF)", "Utensil Rack (FD323) (QB-MF)", "Niagara Washer Disinfector (MD-CFE)", "Anesthesia/Respiratory Rack (FD70400) (QB-MF)", "MIS Rack SS for Vision Washer (FD77900) (QB-MF)", "Reliance Vision Single Chamber Washer/Disinfector (QB-CFE)", "Vision 1327 Cart and Utensil Washer/Disinfector (QB-MF)", "Innowave SI Instrument Tubing (MD-MF)", "Multi-function Rack for Large Item (FD114) (QB-MF)", "Rigid MIS Instrument Rack (FD66400) (QB-MF)", "Vision 1330L Cart and Utensil Washer/Disinfector (QB-MF)", "3 Level Manifold Rack 444 (FD70S600) (QB-MF)", "PCF PRO and Basket (MED11180USA) (MD-CFE)", "AMSCO 7053L Washer/Disinfector (QB-CFE)", "Suction Tips and Instrument Rack (FD72S100) (QB-CFE)", "InnoWave PCF Sonic Irrigator (MD-MF)", "3 Level Manifold Rack (FD009) (QB-MF)", "Niagara Carrier MED1415 (MD-CFE)", "Niagara Sonic Irrigator PCF (MD-CFE)", "Multi-function Rack for Small Items - Large (FD81900) (QB-MF)", "Niagara Carrier MED1450 (MD-CFE)", "Niagara Carrier MED1451 (MD-CFE)", "General Purpose Rack (FD77100) (QB-MF)", "Two Level Manifold Rack with Equal Level Space - Long (FD106) (QB-MF)", "Maxi Rinse Basket IW PCF/SI PCF SI (MD-MF)", "ROBOTIC BASKET FOR PCF DROP+LOCK (MD-MF)", "FOUR Level ORTHOPEDIC Rack - Long (FD109) (QB-MF)", "Two Level Manifold Rack - Long (FD105) (QB-MF)", "da Vinci SI Basket for SI PCF / SI PCF S (MD-MF)", "InnoWave PRO XI Hose and Leur Set (MD-MF)", "Innowave Pro Tray (MD-MF)", "Anesthesia/Respiratory Rack - Long (FD137) (QB-MF)", "MIS Rack (MB000010) (QB-CFE)", "Reliance Vision Multi-Chamber Washer/Disinfector (QB-MF)", "Vision 1321 Cart and Utensil Washer/Disinfector (QB-MF)", "Anesthesia/Respiratory Rack - Large (FD81700) (QB-MF)", "Kidney Bowl Rack (FD02S100) (QB-MF)", "Reliance Synergy Washer/Disinfector (QB-CFE)", "3 Level Opthalmic Rack with Removable Upper Insert - Large (FD82100) (QB-MF)", "AMSCO 3052 Washer/Disinfector (QB-MF)", "3 Level Rack, Equal Space, AMSCO 2532 (FD019) (QB-MF)", "InnoWave Pro Sonic Irrigator (MD-MF)", "AMSCO 7052HP Washer/Disinfector (QB-MF)", "Rack for 5 Sterile Goods Container (FD82000) (QB-MF)", "Niagara Carrier MED1426 (MD-CFE)", "Multi-function Rack for Large Items - Long (FD75500) (QB-MF)", "Four Level Manifold Rack - Long (FD108) (QB-MF)", "Three Level Ophthalmic Rack with Removable Upper Insert - Long (FD79600) (QB-MF)", "2 Level Manifold Rack with Equal Level Space (FD79100) (QB-MF)", "4 Level Orthopetic Rack - Large (FD81400) (QB-MF)", "da Vinci XI Basket for SI PCF / SI PCF S (including Hose & Luer) (MD-MF)", "InnoWave PCF SI Basket and Instrument Tubing (MD-MF)", "2-Level Instrument Rack for Reliance 333 (MB000015) (QB-CFE)", "GPB Rack (FD116) (QB-MF)", "Upper Insert for Ophthalmic Instruments (FD80000) (QB-MF)", "Sonic Irrigator PCF Washer Disinfector and Basket (MED11132) (MD-CFE)", "ROBOTIC BASKET FOR PCF SI DROP+LOCK (MD-MF)", "Glassware Rack wtihout Hooks (CM57) (QB-MF)", "Upper Insert for MIS Instruments (FD79900) (QB-MF)", "InnoWave PCF XI Basket and Instrument Tubing (IW1038) (MD-MF)", "3 Level Manifold Rack (FD74900) (QB-MF)", "3 Level Opthalmic Rack with Removable Upper Insert (FD113) (QB-MF)", "AMSCO 5052 Washer/Disinfector (QB-MF)", "Multi-Purpose Basin Rack (FD02S000) (QB-MF)", "4 Level Suction Tips and Instrument Manifold Rack (FDV72000) (QB-MF)", "Niagara Carrier MED1455 (MD-CFE)", "Anesthesia Rack (FD78000) (QB-MF)", "Instrument Rack (FD360) (QB-MF)", "Reliance Genfore Washer/Disinfector (QB-CFE)", "2 Level Manifold Rack (FD74800) (QB-MF)", "4 Level Manifold Rack ( VSC/VMC/SYN/GEN/3052/5052) - FD75100 (QB-MF)", "3 Level MIS Rack with Removable Upper Insert - Large (FD81600) (QB-MF)", "AMSCO 2532 Washer/Disinfector (QB-MF)", "AMSCO 2532 4 Level Manifold Rack (FD039) (QB-MF)", "FIVE Level Manifold Rack - Long (FD110) (QB-MF)", "Three Level MIS Rack with Removable Upper Insert - Long (FD111) (QB-MF)", "Niagara Carrier MED1437 (MD-CFE)", "Niagara Express and Basket (MD-CFE)", "Multi-function Rack for Small Items - Long (FD75600) (QB-MF)", "5 Level Manifold Rack - Large (FD81500) (QB-MF)", "Basin Rack wtihout Hooks (CM54) (QB-MF)", "AMSCO 7053HP Washer/Disinfector (QB-MF)", "Reliance 1227 Cart and Utensil Washer/Disinfector (QB-MF)", "1 Level General Purpose Rack (CM53) (QB-MF)", "4 Level Manifold Rack - Large (FD81300) (QB-MF)", "Multi-function Rack for Small Items (FD115) (QB-MF)", "2 Level Manifold Rack with Equal Level Space - Large (FD81000) (QB-MF)", "4 Level Manifold Rack (FD026) (QB-MF)", "Xi Multi Basket and tubing (IW1051, MP21906) (MD-MF)", "AMSCO 1215 Cart and Utensil Washer/Disinfector (QB-MF)", "VERIFY All Clean Test Washer Indicator (LCC012) (LC-MF)", "VERIFY All Clean Test Washer Indicator Holder (LCC010) (LC-MF)", "Verify Ultrasonic Indicator (U504) (LC-MF)", "4-Level Single-Chamber Manifold Rack (FD75000) (QB-MF)" ], "establishment_type": [ "Complaint File Establishment per 21 CFR 820.198", "Manufacture Medical Device" ], "registration": { "registration_number": "9680353", "fei_number": "3004097451", "status_code": "1", "initial_importer_flag": "N", "reg_expiry_date_year": "2027", "name": "STERIS Canada ULC", "address_line_1": "490 Boulevard Armand-Paris", "address_line_2": "", "city": "QUEBEC", "state_code": "", "iso_country_code": "CA", "zip_code": "", "postal_code": "G1C 8A3", "us_agent": { "name": "Becky Aldhizer", "business_name": "STERIS Corporation", "bus_phone_area_code": "440", "bus_phone_num": "3927490", "bus_phone_extn": "", "fax_area_code": "", "fax_num": "", "email_address": "becky_aldhizer@steris.com", "address_line_1": "5960 Heisley Rd", "address_line_2": "", "city": "Mentor", "state_code": "OH", "iso_country_code": "US", "zip_code": "44060", "postal_code": "" }, "owner_operator": { "firm_name": "STERIS Corporation", "owner_operator_number": "10078069", "official_correspondent": {}, "contact_address": { "address_1": "5960 Heisley Road", "address_2": "", "city": "Mentor", "state_code": "OH", "state_province": "", "iso_country_code": "US", "postal_code": "44060" } } }, "pma_number": "", "k_number": "", "products": [ { "product_code": "MEC", "created_date": "2020-10-09", "owner_operator_number": "10078069", "exempt": "", "openfda": { "device_name": "Disinfector, Medical Devices", "medical_specialty_description": "General Hospital", "regulation_number": "880.6992", "device_class": "2" } } ] } ] }