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)
Top companies in MLR
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Sterilization Products | 17 | 35 |
| STERIS Corporation | 20 | 11 |
| Plasmapp Co,., Ltd. | 4 | 0 |
| Sterilucent, Inc. | 2 | 0 |
| Ideate Medical, Inc. | 1 | 0 |
| Lowtem Co., Ltd. | 1 | 0 |
| Mdt Corp., Inc. | 1 | 0 |
| Mdt Biologic Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2018 | Steris 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 |
MLR | K172319 |
| Feb 13, 2018 | Steris Corporation V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) Terminated |
MLR | K162413 |
| Feb 14, 2017 | Advanced Sterilization Products STERRAD NX Sterilization System, Product Code: 10033, 10033-002 Terminated |
MLR | K042116 K142454 +1 |
| Aug 13, 2015 | Advanced 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 |
MLR | K142454 |
| Dec 22, 2014 | Advanced 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 |
MLR | K111377 |
| Dec 22, 2014 | Advanced 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 |
MLR | K042116 |
| Dec 22, 2014 | Advanced 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 |
MLR | K030429 |
| Jan 14, 2014 | Advanced 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 |
MLR | K023290 K042116 |
| Dec 31, 2013 | Steris 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 |
MLR | K090036 K101409 +3 |
| Nov 26, 2013 | Advanced 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 |
MLR | K042116 |
| Nov 26, 2013 | Advanced 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 |
MLR | K071385 |
| Nov 8, 2013 | Advanced Sterilization Products Sterrad 100NX, Product Code: 10104.
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Oct 22, 2013 | Advanced 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 |
MLR | K030429 |
| Oct 22, 2013 | Advanced 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 |
MLR | K071385 |
| Sep 10, 2013 | Advanced 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 |
MLR | K071385 |
| Mar 30, 2013 | Advanced 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 |
MLR | K030429 |
| Mar 30, 2013 | Advanced 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 |
MLR | K071385 |
| Mar 26, 2013 | Advanced 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 |
MLR | K030429 |
| Jan 9, 2013 | Advanced 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 |
MLR | None listed |
| Sep 20, 2012 | Steris 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 |
MLR | K897045 |
| Sep 7, 2012 | Advanced 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 |
MLR | K042116 |
| Sep 7, 2012 | Advanced 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 |
MLR | K991999 |
| Jan 13, 2012 | Advanced 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 |
MLR | K030429 |
| Jan 11, 2012 | Advanced 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 |
MLR | K042116 |
| Sep 1, 2011 | Steris 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 |
MLR | K090036 K101409 +1 |
| Aug 19, 2011 | Steris 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 |
MLR | K062297 K083097 |
| Dec 28, 2010 | Steris 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 |
MLR | K040049 |
| Jun 30, 2009 | Advanced Sterilization Products Sterrad 50 Sterilizer, Product Code 10050.
Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K981625 |
| Jun 15, 2009 | Advanced 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 |
MLR | K042116 |
| Dec 2, 2008 | Advanced 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 |
MLR | K042116 |
| Nov 21, 2008 | Advanced 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 |
MLR | K023290 K991999 |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD 100NX Sterilizer, Product Code 10104
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K071385 |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD NX Sterilizer, Product Code 10033
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K042116 |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD 200 Sterilization System, Product Code 10201
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K030429 |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD 50 Sterilization System, Product Code 10050
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K023290 K981625 |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD 100S Sterilization System, Product Code 10101
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K023290 K991999 |
| Feb 8, 2008 | Advanced Sterilization Products STERRAD NX Sterilizer, Product Code: 10033, Advanced Sterilization Products, Irvine, CA Terminated |
MLR | None listed |
| Feb 8, 2008 | Advanced Sterilization Products STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CA Terminated |
MLR | None listed |
| Feb 8, 2008 | Advanced Sterilization Products STERRAD 50 Sterilizer, Product Code:10050, Advanced Sterilization Products, Irvine, CA Terminated |
MLR | None listed |
| Feb 8, 2008 | Advanced Sterilization Products STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA Terminated |
MLR | K030429 K981625 +1 |
| Feb 7, 2008 | Advanced 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 |
MLR | K030429 K042116 +2 |
| Nov 24, 2005 | Advanced Sterilization Products Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S Terminated |
MLR | K991999 |
| May 15, 2003 | Steris Corp C1140 Flexible Endoscope Processing Container and Tray assembly. Terminated |
MLR | None listed |
| May 15, 2003 | Steris 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 |
MLR | None listed |
| Apr 16, 2003 | Steris 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 |
MLR | None listed |
| Feb 6, 2003 | Steris 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 |
MLR | K875280 |
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