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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
DateFirm and productCodeLinked 510(k)
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM6
Open, Classified
MEDK930284
K931052
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Model Number: 4455AW
Open, Classified
MEDK080420
Jul 5, 2019Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Terminated
MEDK931052
Sep 2, 2016Best Sanitizers Inc
Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.
Terminated
MEDK091210
Dec 4, 2015Steris Corporation
Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant a
Terminated
MEDK131078
Sep 16, 2015Advanced Sterilization Products
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
Terminated
MEDK030004
Aug 25, 2015Advanced Sterilization Products
CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
Terminated
MEDK060618
Jun 26, 2013Steris Corporation
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart a
Terminated
MEDK113520
Sep 7, 2012Steris Corporation
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critic
Terminated
MEDK090036
K101409 +1
Aug 28, 2012Steris Corporation
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Terminated
MEDK090036
Aug 27, 2012Advanced Sterilization Products
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Terminated
MEDK030004
Jan 25, 2012Steris Corporation Hopkins Facility
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The
Terminated
MEDK090036
K102462
Apr 12, 2011Steris Corporation Hopkins Facility
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressib
Terminated
MEDK090036
K101409 +1
Sep 23, 2008Steris Corp
Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K SERIES GI ENDOSCOPES WITH WATE
Terminated
MEDK875280
Aug 5, 2008Steris Corp
Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.
Terminated
MEDNone listed
Oct 24, 2007Steris Corporation Hopkins Facility
Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 20
Terminated
MEDNone listed
Oct 6, 2007I-Flow Corporation
ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A.
Terminated
MEDK932740
Jun 21, 2007Steris Corp
Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Wat
Terminated
MEDNone listed
Dec 7, 2005Pascal Co Inc
product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Man
Terminated
MEDK012889
Oct 28, 2004Advanced Sterilization Products
CIDEX OPA Solution, ortho-Phthalaldehyde Solution
Terminated
MEDK002401
Jul 20, 2004Steris Corp
QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680
Terminated
MEDK875280

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