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Panels › General Hospital › Product code MED · Class 2

Sterilant, Medical Devices

Regulation 880.6885

2510(k)s in 12 months (65 all time)
0recalls in 12 months (21 all time)
18recalls that name a 510(k)
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Top companies in MED

Company510(k)sRecalls
STERIS Corporation198
Advanced Sterilization Products54
Best Sanitizers, Inc.21
Cottrell, Ltd.30
Metrex Research Corp.30
Steris Corporation Hopkins Facility03
Ciden Technologies, LLC20
Healthpoint, Ltd.20
Mckesson Medical-Surgical Inc. Corporate Office02
Minntech Corp.20
Decided510(k)Device and applicantCode
Oct 16, 2026K254094Endox High Level Disinfectant
Whiteley USA, Inc.
MED
Apr 8, 2026K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing S
STERIS Corporation
MED
Oct 3, 2023K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System
STERIS Corporation
MED
Mar 28, 2023K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
STERIS Corporation
MED
Sep 28, 2022K222615SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model
STERIS Corporation
MED
Sep 7, 2021K211607SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model
STERIS Corporation
MED
May 12, 2021K210737SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model
STERIS Corporation
MED
Dec 10, 2019K192929SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model
STERIS Corporation
MED
Sep 5, 2019K191343SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
STERIS Corporation
MED
Mar 22, 2019K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
Steris Corporations
MED
Jan 31, 2019K182827SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
STERIS Corporation
MED
Apr 4, 2018K180342SYSTEM 1E Liquid Chemical Sterilant Processing System
Steris Corporations
MED
Mar 2, 2018K173256System 1 endo Liquid Chemical Sterilant Processing System
STERIS Corporation
MED
Sep 22, 2017K170956SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation
MED
Aug 5, 2016K161683SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation
MED
Aug 19, 2014K140703OPA 30 SOLUTION
Ciden Technologies, LLC
MED
Jul 5, 2013K131078SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
STERIS Corporation
MED
Sep 27, 2012K120306RAPICIDE OPA-28
Minntech Corp.
MED
Feb 21, 2012K113520SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
STERIS Corporation
MED
Jan 30, 2012K113015ALDAHOL V HIGH LEVEL DISINFECTANT
Microchem Laboratories, Inc.
MED
Sep 21, 2010K102462SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
STERIS Corporation
MED
Aug 2, 2010K101409SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
STERIS Corporation
MED
Apr 12, 2010K091022MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
STERIS Corporation
MED
Apr 5, 2010K090036SYSTEM 1.5 STERILE PROCESSING SYSTEM
STERIS Corporation
MED
Mar 24, 2010K091890EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
Healthpoint, Ltd.
MED
Feb 5, 2010K091210ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT
Best Sanitizers, Inc.
MED
Sep 2, 2008K080420RESERT XL HLD HIGH LEVEL DISINFECTANT
STERIS Corporation
MED
Aug 2, 2007K070627OPACIDEN SOLUTION
Ciden Technologies, LLC
MED
Apr 2, 2007K063159STERILOX LIQUID CHEMICAL STERILANT SYSTEM
Puricore, Inc.
MED
Jul 3, 2006K061356POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6
Advanced Infusion, Inc.
MED
Apr 12, 2006K060618CIDEX ACTIVATED DIALDEHYDE SOLUTION
Johnson & Johnson Co.
MED
May 11, 2005K041984ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
Best Sanitizers, Inc.
MED
May 5, 2005K041360ALDAHOL III HIGH-LEVEL DISINFECTANT
Healthpoint, Ltd.
MED
Apr 4, 2005K032959CIDEX OPA CONCENTRATE
Advanced Sterilization Products
MED
Jan 27, 2004K033381DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
Discus Dental, Inc.
MED
May 27, 2003K012889BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
Pascal Co., Inc.
MED
Feb 27, 2003K0300040.55% ORTH-PHTHALALDEHYDE SOLUTION
Advanced Sterilization Products
MED
Sep 18, 2002K013280STERILOX LIQUID CHEMICAL STERILANT SYSTEM
Sterilox Technologies, Inc.
MED
Nov 7, 2000K003087MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
Sporicidin Intl.
MED
Aug 29, 2000K002401CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
Advanced Sterilization Products
MED
Aug 17, 2000K993042MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
Medivators, Inc.
MED
May 17, 2000K001381CIDEX OPA SOLUTION
Advanced Sterilization Products
MED
Oct 8, 1999K991487CIDEX OPA SOLUTION
Advanced Sterilization Products
MED
Sep 13, 1999K972708ENDO-SPOR PLUS / HYPROCIDE
Cottrell, Ltd.
MED
May 20, 1999K984270VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
Roger L. Goodman, D.D.S., P.C.
MED
Mar 30, 1999K990703SPOROX II STERILIZING & DISINFECTING SOLUTION
Reckitt Benckiser, Inc.
MED
Mar 5, 1999K983194SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
Sporicidin Intl.
MED
Sep 10, 1998K974188CETYLCIDE-G
Kellerandheckman
MED
Sep 2, 1998K974062MEDSCI 3% GLUTARALDEHYDE
Medsci, Inc.
MED
Jun 5, 1998K962959PERACIDIN DIALYZER REPROCESSING CONCENTRATE
Hdc Medical, Inc.
MED

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