279 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biological Indicator Pack Steam Model Number: S3069. d. STERIS CORP Celerity Celerity Sterilization Biological Indicator Vial Vaporized Hydrogen Peroxide Model Number:LCB044. e. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB049. f. STERIS CORP VERIFY Sterilization Indicator Challenge Pack Steam Catalog #LCB035.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
FDA Enforcement
Class II
·Terminated·Steris Corporation·September 5, 2012
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·October 17, 2012
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
FDA Enforcement
Class II
·Ongoing·Steris Corporation·May 10, 2023
3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·April 9, 2014
VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 19, 2014
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER (1) DRAPE THYROID 100" X 142" X 72" (1) TAPE TEGADERM 2-3/8 X 2-3/4 (1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP (2) GAUZE SPONGE 2" X 2" 4PLY NON WOVEN (1) STRIP STERI CLOSURE %'' X 4" (2) GOWN SOFT SMS STD XL SET IN SLEEVE (4) NEEDLE HYPODERMIC 18G X 1 % (1) RULER FLEXIBLE PLASTIC (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK (1) BAG ZIP LOCK (1) STRIP STERI DRAPE LARGE 17" X 23" (9) LABELS FOR SKIN MARKERS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
FDA Enforcement
Class II
·Terminated·Steris Corporation·July 16, 2014
AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
FDA Enforcement
Class II
·Terminated·Steris Corporation·May 6, 2015
VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 8, 2014
LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) STRIP STERI DRAPE LARGE 17" X 23" UF (1) SCALPEL WITH HANDLE #11 (1) COVER FLUORO 30" X 30" WITH RUBBER BAND UF (1) DRAPE CHEST 100" X 142" X 72" (1) RULER FLEXIBLE PLASTIC (1) SOLUTION SURGICAL DURAPREP 26ML UF (1) SHEET :X 60" X 77" DRAPE REINFORCED UF (1) STRIP STERI CLOSURE%'' X 4" UF (2) GOWN SOFT SMS STD. XL SET IN SLEEVE UF (4) NEEDLE HYPODERMIC 18G X 1 % U (1) SKIN MARKER W/RULER UF (1) NEEDLE HYPODERMIC 25 X 1 % UF (1) DRESSING TELFA 8" X 3" NON ADH UF (1) DRESSING TEGADERM 4 X 4%" UF (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VIALL /F (1) BAG ZIP LOCK UF (9) LABELS FOR SKIN MARKERS UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·May 4, 2016
3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022