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Panels › General Hospital › Product code MLR · Class 2

Sterilizer, Chemical

Regulation 880.6860

1510(k)s in 12 months (47 all time)
0recalls in 12 months (46 all time)
38recalls that name a 510(k)
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Top companies in MLR

DateFirm and productCodeLinked 510(k)
Jul 26, 2018Steris Corporation
AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intend
Terminated
MLRK172319
Feb 13, 2018Steris Corporation
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Terminated
MLRK162413
Feb 14, 2017Advanced Sterilization Products
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Terminated
MLRK042116
K142454 +1
Aug 13, 2015Advanced Sterilization Products
Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
Terminated
MLRK142454
Dec 22, 2014Advanced Sterilization Products
STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive re
Terminated
MLRK111377
Dec 22, 2014Advanced Sterilization Products
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusa
Terminated
MLRK042116
Dec 22, 2014Advanced Sterilization Products
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reus
Terminated
MLRK030429
Jan 14, 2014Advanced Sterilization Products
STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganism
Terminated
MLRK023290
K042116
Dec 31, 2013Steris Corporation
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical ster
Terminated
MLRK090036
K101409 +3
Nov 26, 2013Advanced Sterilization Products
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK042116
Nov 26, 2013Advanced Sterilization Products
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK071385
Nov 8, 2013Advanced Sterilization Products
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRNone listed
Oct 22, 2013Advanced Sterilization Products
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer us
Terminated
MLRK030429
Oct 22, 2013Advanced Sterilization Products
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK071385
Sep 10, 2013Advanced Sterilization Products
STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK071385
Mar 30, 2013Advanced Sterilization Products
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate micro
Terminated
MLRK030429
Mar 30, 2013Advanced Sterilization Products
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate
Terminated
MLRK071385
Mar 26, 2013Advanced Sterilization Products
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Terminated
MLRK030429
Jan 9, 2013Advanced Sterilization Products
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The ster
Terminated
MLRNone listed
Sep 20, 2012Steris Corporation
Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chem
Terminated
MLRK897045
Sep 7, 2012Advanced Sterilization Products
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medi
Terminated
MLRK042116
Sep 7, 2012Advanced Sterilization Products
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable me
Terminated
MLRK991999
Jan 13, 2012Advanced Sterilization Products
STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used
Terminated
MLRK030429
Jan 11, 2012Advanced Sterilization Products
STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture
Terminated
MLRK042116
Sep 1, 2011Steris Corporation
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: The SYSTEM 1E Liquid Chemical Sterilan
Terminated
MLRK090036
K101409 +1
Aug 19, 2011Steris Corporation
Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. The STERIS Amsco V-PRO and V-PRO 1 Plus Low Temperature Sterilizer are self-con
Terminated
MLRK062297
K083097
Dec 28, 2010Steris Corporation
Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada. Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable
Terminated
MLRK040049
Jun 30, 2009Advanced Sterilization Products
Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK981625
Jun 15, 2009Advanced Sterilization Products
STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devi
Terminated
MLRK042116
Dec 2, 2008Advanced Sterilization Products
STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical instruments.
Terminated
MLRK042116
Nov 21, 2008Advanced Sterilization Products
STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to st
Terminated
MLRK023290
K991999
Aug 8, 2008Advanced Sterilization Products
STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK071385
Aug 8, 2008Advanced Sterilization Products
STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK042116
Aug 8, 2008Advanced Sterilization Products
STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK030429
Aug 8, 2008Advanced Sterilization Products
STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK023290
K981625
Aug 8, 2008Advanced Sterilization Products
STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and moisture sensitive reusable medical devices.
Terminated
MLRK023290
K991999
Feb 8, 2008Advanced Sterilization Products
STERRAD NX Sterilizer, Product Code: 10033, Advanced Sterilization Products, Irvine, CA
Terminated
MLRNone listed
Feb 8, 2008Advanced Sterilization Products
STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CA
Terminated
MLRNone listed
Feb 8, 2008Advanced Sterilization Products
STERRAD 50 Sterilizer, Product Code:10050, Advanced Sterilization Products, Irvine, CA
Terminated
MLRNone listed
Feb 8, 2008Advanced Sterilization Products
STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA
Terminated
MLRK030429
K981625 +1
Feb 7, 2008Advanced Sterilization Products
STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference
Terminated
MLRK030429
K042116 +2
Nov 24, 2005Advanced Sterilization Products
Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
Terminated
MLRK991999
May 15, 2003Steris Corp
C1140 Flexible Endoscope Processing Container and Tray assembly.
Terminated
MLRNone listed
May 15, 2003Steris Corp
C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be sold individually or with the processing tray assembly (C1140).
Terminated
MLRNone listed
Apr 16, 2003Steris Corp
QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the STERIS SYSTEM I Processor and the C1160 Universal Flexible Processing Tray. The QFC1631 is
Terminated
MLRNone listed
Feb 6, 2003Steris Corp
C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.
Terminated
MLRK875280

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