Advanced Sterilization Products
Advanced Sterilization Products holds FDA 510(k) medical device clearances, first cleared 1994, most recent 2024, with 36 FDA device recalls on record.
Top product codes for Advanced Sterilization Products
FDA recalls by Advanced Sterilization Products
10 most recent of 36- Z-1197-2017 — STERRAD NX Sterilization System, Product Code: 10033, 10033-002
- Z-0965-2017 — EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.
- Z-2774-2015 — CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
- Z-2459-2015 — CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
- Z-2375-2015 — 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.
- Z-1715-2015 — EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
- Z-1714-2015 — EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
- Z-1312-2015 — Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
- Z-0845-2015 — 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 reusable medical devices.
- Z-0846-2015 — 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 reusable medical devices.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Advanced Sterilization Products
- K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more
- K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
- K162007 — STERRAD NX Sterilizer
- K160818 — STERRAD® NX Sterilizer with ALLClear Technology
- K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology
- K151725 — STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
- K151971 — STERRAD CYCLESURE 24 Biological Indicator
- K142454 — STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
- K140977 — EVOTECH ECR
- K141693 — Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
- K130263 — STERRAD 50/100S/200 TEST PACK
- K123017 — STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324
- K112087 — TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS
- K122044 — STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
- K111518 — STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
- K111519 — STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202
- K111391 — STERRAD (R) 100NX DUO CYCLE TEST PACK
- K111375 — STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
- K111377 — STERRAD(R) 100NX STERILIZER DUO CYCLE
- K103210 — TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
- K103218 — STERRAD CHEMICAL INDICATOR STRIP
- K103219 — STERRAD SEALSURE CHEMICAL INDICATOR TAPE
- K092622 — STERRAD 100NX STERILIZER EXPRESS CYCLE
- K092755 — STERRAAD 100NX EXPRESS CYCLE TEST PACK
- K103222 — STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K102884 — STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
- K082392 — EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
- K071537 — STERRAD 100NX TEST PACK
- K071385 — STERRAD 100NX STERILIZER
- K071014 — MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K061899 — EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
- K051643 — STERRAD STERILIZER CYCLESURE TEST PACK
- K042450 — STERRAD NX CHALLENGE PACK
- K042116 — STERRAD NX STERILIZER
- K032959 — CIDEX OPA CONCENTRATE
- K040883 — EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
- K040742 — MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
- K030429 — STERRAD 200 STERILIZER
- K031226 — STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K023290 — STERRAD 50 & STERRAD 100S STERILIZERS
- K030004 — 0.55% ORTH-PHTHALALDEHYDE SOLUTION
- K022441 — STERRAD SEALSURE CHEMICAL INDICATOR TAPE
- K013003 — APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
- K994055 — STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K002401 — CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
- K991999 — STERRAD 100S STERILIZER
- K993775 — STERRAD BI TEST PACK
- K001381 — CIDEX OPA SOLUTION
- K991487 — CIDEX OPA SOLUTION
- K991675 — MODIFICATION OF: STERRAD BI TEST PACK
- K981625 — STERRAD 50 STERILIZER
- K954142 — STERRADD STERILIZATION SYSTEM
- K951295 — STERRAD STERILIZATION POUCH
- K945190 — STERRAD CHEMICAL INDICATOR TAPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.