Steris Laboratories

FDA Filings

This page includes the latest FDA filings for Steris Laboratories. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2183828
• FEI Number: 2183828
• Name: STERIS Laboratories
• Owner & Operator: STERIS Corporation
• Contact Address: 5960 Heisley Rd --; Mentor OH 44060 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9303 West Broadway Ave. ; Brooklyn Park, MN 55445 US
• Establishment Type:
  • Sterilize Medical Device for Another Party (Contract Sterilizer)
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PMN BP170122 | QCZ STERIS Laboratories [STERIS Corporation]	Avita RECELL	2019-11-01
PMN K151146 | HWC STERIS Laboratories [STERIS Corporation]	Innovision - N-Force 7.3 Fixation Sytem Sheath & Adapter Assembly	2018-02-15
PMN K151146 | HWC STERIS Laboratories [STERIS Corporation]	Innovision - N-Force 7.3 Fixation System Standard Washer Assembly	2018-02-15
PMN K151146 | HWC STERIS Laboratories [STERIS Corporation]	Innovision - N-Force 7.3 Fixation System Non-fenestrated Screw & Washer Assembly	2018-02-15
PMN K151146 | HWC STERIS Laboratories [STERIS Corporation]	Innovision - N-Force 7.3 Fixation System Inset Washer Assembly	2018-02-15
PMN K151146 | HWC STERIS Laboratories [STERIS Corporation]	Innovision - N-Force 7.3 Fixation System Fenestrated Screw, Washer, Sheath & Adapter Assembly	2018-02-15
PMN K151146 | HWC STERIS Laboratories [STERIS Corporation]	Innovision - N-Force 4.0 Fixation System Sheath & Adapter Assembly	2018-02-15
PMN K151146 | HWC STERIS Laboratories [STERIS Corporation]	Innovision - N-Force 4.0 Fixation System Partially Cannulated Screw, Sheath & Adapter Assembly	2018-02-15
PMN K151146 | HWC STERIS Laboratories [STERIS Corporation]	Innovision - N-Force 4.0 Fixation System Inset Washer Assembly	2018-02-15
PMN K151146 | HWC STERIS Laboratories [STERIS Corporation]	Innovision - N-Force 4.0 Fixation System Fully Cannulated Screw, Sheath & Adapter Assembly	2018-02-15
FLD STERIS Laboratories [STERIS Corporation]	Delcath Dual Hemofiltration Cartridge	2018-01-09
PMN K152441 | LHI STERIS Laboratories [STERIS Corporation]	Kiro Grifols - KIRO Set	2016-11-22
PMN P980031 | LQE STERIS Laboratories [STERIS Corporation]	Addition Technology - INTACS?	2015-01-29
PMN K894038 | FYD STERIS Laboratories [STERIS Corporation]	miniSquair	2014-03-03
BSR STERIS Laboratories [STERIS Corporation]	Verathon Medical -GlideRite Single-Use Stylet - Small	2014-03-03
GFD STERIS Laboratories [STERIS Corporation]	Dermatome	2014-02-13
PMN P950002 | MAX STERIS Laboratories [STERIS Corporation]	Implant, BP/Lordotic Interbody	2013-06-03
PMN P950002 | MAX STERIS Laboratories [STERIS Corporation]	Implant, BP Interbody	2013-06-03
PMN P950002 | MAX STERIS Laboratories [STERIS Corporation]	BAK/Proximity Interbody	2013-06-03
PMN P950002 | MAX STERIS Laboratories [STERIS Corporation]	BAK/L Interbody	2013-06-03
PMN K111796 | KWQ STERIS Laboratories [STERIS Corporation]	inViZia Fixation Pin , Sterile	2013-06-03
PMN K111796 | KWQ STERIS Laboratories [STERIS Corporation]	inViZia Drill, Sterile	2013-06-03
PMN K111796 | KWQ STERIS Laboratories [STERIS Corporation]	inViZia Drill Bits, Sterile	2013-06-03
PMN K111796 | KWQ STERIS Laboratories [STERIS Corporation]	inViZia Compression Pin , Sterile	2013-06-03
PMN K080367 | FST STERIS Laboratories [STERIS Corporation]	Zimmer (MIS Light)	2013-06-03
PMN K080367 | FST STERIS Laboratories [STERIS Corporation]	Light Pipe	2013-06-03
HOC STERIS Laboratories [STERIS Corporation]	Visitec	2012-12-28
HOC STERIS Laboratories [STERIS Corporation]	Oasis Iris Expander	2012-12-28
HOC STERIS Laboratories [STERIS Corporation]	Microsurgical Tech Inc ST Malyugin Ring 2.0	2012-12-28
HOC STERIS Laboratories [STERIS Corporation]	Microsurgical Tech Inc MST MALYUGIN RING SYSTEM	2012-12-28
HOC STERIS Laboratories [STERIS Corporation]	Microsurgical Tech Inc MST Iris Hooks	2012-12-28
HTW STERIS Laboratories [STERIS Corporation]	Zimmer Biomet - Titanium Interference Screws	2012-12-27
HTW STERIS Laboratories [STERIS Corporation]	Parcus Drill Bits	2012-12-27
GEA STERIS Laboratories [STERIS Corporation]	Disposable Cannulas	2012-12-27
DWS STERIS Laboratories [STERIS Corporation]	QTS - Guidewire Introducer Needles	2012-12-27
DWS STERIS Laboratories [STERIS Corporation]	Merit Medical - Worley Slitter	2012-12-27
DWS STERIS Laboratories [STERIS Corporation]	Merit Medical - Transavalvular Insertion tool (TVI)	2012-12-27
DWS STERIS Laboratories [STERIS Corporation]	Merit Medical - Cutter	2012-12-27
DWS STERIS Laboratories [STERIS Corporation]	Merit Medical - Contamination Sleeve	2012-12-27
DWS STERIS Laboratories [STERIS Corporation]	Atrion Medical - Aortic Punch	2012-12-27
LXH STERIS Laboratories [STERIS Corporation]	Spine Wave - GraftMag Disposable Kit	2012-10-31
LXH STERIS Laboratories [STERIS Corporation]	QTS - Universe Spinous Process Fixation Plate System	2012-10-31
LXH STERIS Laboratories [STERIS Corporation]	QTS - TwinLoop Flex Instrumentation	2012-10-31
LXH STERIS Laboratories [STERIS Corporation]	QTS - Suture Sliders	2012-10-31
LXH STERIS Laboratories [STERIS Corporation]	QTS - Stryker Universal ACL Instrumentation System	2012-10-31
LXH STERIS Laboratories [STERIS Corporation]	QTS - OptiMesh Instruments	2012-10-31
LXH STERIS Laboratories [STERIS Corporation]	QTS - ICONIX All Suture Anchor System	2012-10-31
LXH STERIS Laboratories [STERIS Corporation]	QTS - Distraction Screws	2012-10-31
LXH STERIS Laboratories [STERIS Corporation]	Innovative Surgical Designs - True Spinal Fixation System	2012-10-31