FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K061356 |
ADVANCED INFUSION, INC. |
POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 |
07/03/2006 |
K030004 |
ADVANCED STERILIZATION PRODUCTS |
0.55% ORTH-PHTHALALDEHYDE SOLUTION |
02/27/2003 |
K032959 |
ADVANCED STERILIZATION PRODUCTS |
CIDEX OPA CONCENTRATE |
04/04/2005 |
K001381 |
ADVANCED STERILIZATION PRODUCTS |
CIDEX OPA SOLUTION |
05/17/2000 |
K991487 |
ADVANCED STERILIZATION PRODUCTS |
CIDEX OPA SOLUTION |
10/08/1999 |
K002401 |
ADVANCED STERILIZATION PRODUCTS |
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) |
08/29/2000 |
K041984 |
BEST SANITIZERS, INC. |
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT |
05/11/2005 |
K091210 |
BEST SANITIZERS, INC. |
ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT |
02/05/2010 |
K140703 |
CIDEN TECHNOLOGIES LLC |
OPA 30 SOLUTION |
08/19/2014 |
K070627 |
CIDEN TECHNOLOGIES LLC |
OPACIDEN SOLUTION |
08/02/2007 |
K972708 |
COTTRELL, LTD. |
ENDO-SPOR PLUS / HYPROCIDE |
09/13/1999 |
K970726 |
COTTRELL, LTD. |
VAPOCIDE |
05/18/1998 |
K033381 |
DISCUS DENTAL INC. |
DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL |
01/27/2004 |
K961289 |
GERMIPHENE CORP. |
VAPOPHENE |
12/04/1997 |
K962959 |
HDC MEDICAL, INC. |
PERACIDIN DIALYZER REPROCESSING CONCENTRATE |
06/05/1998 |
K041360 |
HEALTHPOINT, LTD. |
ALDAHOL III HIGH-LEVEL DISINFECTANT |
05/05/2005 |
K091890 |
HEALTHPOINT, LTD. |
EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT |
03/24/2010 |
K060618 |
JOHNSON & JOHNSON CO. |
CIDEX ACTIVATED DIALDEHYDE SOLUTION |
04/12/2006 |
K974188 |
KELLER AND HECKMAN |
CETYLCIDE-G |
09/10/1998 |
K993042 |
MEDIVATORS, INC. |
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT |
08/17/2000 |
K974062 |
MEDSCI, INC. |
MEDSCI 3% GLUTARALDEHYDE |
09/02/1998 |
K113015 |
MICROCHEM LABORATORIES, INC. |
ALDAHOL V HIGH LEVEL DISINFECTANT |
01/30/2012 |
K960513 |
MINNTECH CORP. |
PERACT 20 LIQUID STERILANT |
10/01/1997 |
K120306 |
MINNTECH CORP. |
RAPICIDE OPA-28 |
09/27/2012 |
K012889 |
PASCAL CO., INC. |
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT |
05/27/2003 |
K063159 |
PURICORE, INC. |
STERILOX LIQUID CHEMICAL STERILANT SYSTEM |
04/02/2007 |
K970230 |
RECKITT BENCKISER, INC. |
SPOROX |
10/29/1997 |
K990703 |
RECKITT BENCKISER, INC. |
SPOROX II STERILIZING & DISINFECTING SOLUTION |
03/30/1999 |
K984270 |
ROGER L. GOODMAN, D.D.S., P.C. |
VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 |
05/20/1999 |
K003087 |
SPORICIDIN INTL. |
MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION |
11/07/2000 |
K983194 |
SPORICIDIN INTL. |
SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) |
03/05/1999 |
K013280 |
STERILOX TECHNOLOGIES, INC. |
STERILOX LIQUID CHEMICAL STERILANT SYSTEM |
09/18/2002 |
K091022 |
STERIS Corporation |
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT |
04/12/2010 |
K080420 |
STERIS Corporation |
RESERT XL HLD HIGH LEVEL DISINFECTANT |
09/02/2008 |
K173256 |
Steris Corporation |
System 1 endo Liquid Chemical Sterilant Processing System |
03/02/2018 |
K182827 |
STERIS Corporation |
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 |
01/31/2019 |
K230582 |
STERIS Corporation |
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 |
03/28/2023 |
K191343 |
STERIS Corporation |
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 |
09/05/2019 |
K090036 |
STERIS Corporation |
SYSTEM 1.5 STERILE PROCESSING SYSTEM |
04/05/2010 |
K131078 |
STERIS Corporation |
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM |
07/05/2013 |
K161683 |
STERIS CORPORATION |
SYSTEM 1E Liquid Chemical Sterilant Processing System |
08/05/2016 |
K170956 |
STERIS Corporation |
SYSTEM 1E Liquid Chemical Sterilant Processing System |
09/22/2017 |
K102462 |
STERIS Corporation |
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM |
09/21/2010 |
K113520 |
STERIS Corporation |
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM |
02/21/2012 |
K232914 |
STERIS Corporation |
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) |
10/03/2023 |
K192929 |
STERIS Corporation |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 |
12/10/2019 |
K210737 |
STERIS Corporation |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate |
05/12/2021 |
K211607 |
STERIS Corporation |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate |
09/07/2021 |
K222615 |
STERIS Corporation |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate |
09/28/2022 |
K101409 |
STERIS Corporation |
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM |
08/02/2010 |
K180342 |
Steris Corporations |
SYSTEM 1E Liquid Chemical Sterilant Processing System |
04/04/2018 |
K190104 |
Steris Corporations |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System |
03/22/2019 |