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)
Top companies in MED
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 19 | 8 |
| Advanced Sterilization Products | 5 | 4 |
| Best Sanitizers, Inc. | 2 | 1 |
| Cottrell, Ltd. | 3 | 0 |
| Metrex Research Corp. | 3 | 0 |
| Steris Corporation Hopkins Facility | 0 | 3 |
| Ciden Technologies, LLC | 2 | 0 |
| Healthpoint, Ltd. | 2 | 0 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 2 |
| Minntech Corp. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson 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 |
MED | K930284 K931052 |
| Aug 26, 2022 | Mckesson 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 |
MED | K080420 |
| Jul 5, 2019 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution Terminated |
MED | K931052 |
| Sep 2, 2016 | Best 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 |
MED | K091210 |
| Dec 4, 2015 | Steris 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 |
MED | K131078 |
| Sep 16, 2015 | Advanced Sterilization Products CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices. Terminated |
MED | K030004 |
| Aug 25, 2015 | Advanced Sterilization Products CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 Terminated |
MED | K060618 |
| Jun 26, 2013 | Steris 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 |
MED | K113520 |
| Sep 7, 2012 | Steris 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 |
MED | K090036 K101409 +1 |
| Aug 28, 2012 | Steris Corporation QKC1692E
The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor. Terminated |
MED | K090036 |
| Aug 27, 2012 | Advanced 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 |
MED | K030004 |
| Jan 25, 2012 | Steris 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 |
MED | K090036 K102462 |
| Apr 12, 2011 | Steris 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 |
MED | K090036 K101409 +1 |
| Sep 23, 2008 | Steris 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 |
MED | K875280 |
| Aug 5, 2008 | Steris Corp Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes. Terminated |
MED | None listed |
| Oct 24, 2007 | Steris 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 |
MED | None listed |
| Oct 6, 2007 | I-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 |
MED | K932740 |
| Jun 21, 2007 | Steris 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 |
MED | None listed |
| Dec 7, 2005 | Pascal 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 |
MED | K012889 |
| Oct 28, 2004 | Advanced Sterilization Products CIDEX OPA Solution, ortho-Phthalaldehyde Solution Terminated |
MED | K002401 |
| Jul 20, 2004 | Steris 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 |
MED | K875280 |
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