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Panels › General Hospital › Product code FRG · Class 2

Wrap, Sterilization

Regulation 880.6850

5510(k)s in 12 months (323 all time)
0recalls in 12 months (50 all time)
50recalls that name a 510(k)
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Top companies in FRG

Company510(k)sRecalls
STERIS Corporation843
Kimberly-Clark Corp.111
Cardinal Health200, LLC110
Medline Industries, Inc.110
Case Medical, Inc.90
Turbett Surgical44
Custom Pack Reliability70
Wipak OY70
Aesculap60
Andersen Sterilizers, Inc.60
Decided510(k)Device and applicantCode
Jul 2, 2026K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE
O&M Halyard, Inc.
FRG
May 28, 2026K252823Dukal Crepe Paper Sterilization Wrap
Dukal, LLC
FRG
May 18, 2026K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap
O&M Halyard, Inc.
FRG
Jan 28, 2026K251347Sterilization Pouch/Roll
Sterivic Medical Co., Ltd., CN
FRG
Dec 12, 2025K251177Self-Seal Sterilization Pouch and Roll
Guangdong Maidi Medical Co., Ltd., CN
FRG
Oct 31, 2025K250306Chex-All Sterilization Pouches and Tubes
Propper Manufacturing Co., Inc.
FRG
Jun 26, 2025K243179Sterilization Pouch and Roll
Yichang Xinxin Paper Products Co., Ltd., CN
FRG
Jun 6, 2025K250321GCI Sterilization Wrappers
George Courey, Inc., CA
FRG
Apr 25, 2025K243721Self Sealing Sterilization Pouches
Wellmed Dental Medical Supply Co., Ltd., CN
FRG
Apr 4, 2025K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1
Turbett Surgical
FRG
Feb 24, 2025K241565Sterilization Package/Reel
Anqing Clean Dental Instrument Technology Co., Ltd., CN
FRG
Feb 21, 2025K243431Medicom Sterilization Pouch and Reel
Medicom Asia-Pacific Holdings Ltd. Taiwan Branch., TW
FRG
Feb 21, 2025K242898Sterilization Pouches and Reels
Shanghai Jianzhong Medical Packaging Co., Ltd., CN
FRG
Nov 4, 2024K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)
Comercializadora Brever, MX
FRG
Oct 16, 2024K242839Safe Secure Sterilization Pouches and Rolls
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd., CN
FRG
Oct 7, 2024K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
Primed Medical Products, Inc., CA
FRG
Sep 18, 2024K241123Perpak™ Sterilization Tyvek Pouch
Km Corp., KR
FRG
Sep 17, 2024K234132Medline Reusable Sterilization Wrappers
Medline Industries, LP
FRG
Sep 16, 2024K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap
O&M Halyard, Inc.
FRG
Aug 7, 2024K240330HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
O&M Halyard, Inc.
FRG
Jun 21, 2024K240862Medicom Sterilization Wrap
Medicom Group, Inc., CA
FRG
Jun 7, 2024K232625Steriking® Pouch for Robotic Instruments
Wipak OY, FI
FRG
May 24, 2024K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
Primed Medical Products, Inc., CA
FRG
Mar 22, 2024K233262Dukal SMS Sterilization Wrap
Dukal, LLC
FRG
Dec 7, 2023K230137Reliance® Fusion Sterilization Wraps
Ahlstrom-Munksjo Nonwovens, LLC
FRG
Sep 7, 2023K231999Steriking® LT-Blueline Pouches with Tyvek®
Wipak OY, FI
FRG
Sep 7, 2023K231996Steriking® LT-Blueline Pouches with Tyvek®
Wipak OY, FI
FRG
Aug 25, 2023K223600Sterilization Wrap
Wuhan Zonsen Medical Products Co., Ltd., CN
FRG
Aug 7, 2023K231500Vis-U-All Low Temperature Sterilization Pouches
STERIS Corporation
FRG
May 9, 2023K223025Tyvek Roll with CI for STERLINK Sterilizer
Plasmapp Co,., Ltd., KR
FRG
Mar 23, 2023K222151Sterilization Wrap
Kenpax International Limited, CN
FRG
Feb 13, 2023K221875Sterilization Pouch and Roll
Qianjiang Kingphar Medical Packaging & Printing Co., Ltd., CN
FRG
Jan 4, 2023K221379Steriking LT-Blueline Pouches with Tyvek
Wipak OY, FI
FRG
Dec 22, 2022K221377SteriKing LT-Blueline Pouches with Tyvek
Wipak OY, FI
FRG
Oct 6, 2022K220365Gemini Sterilization Wrap
Medline Industries, LP
FRG
Sep 9, 2022K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
Steris
FRG
Aug 3, 2022K191131Solidence Multipockets
Solidence Surgical Corporation
FRG
Jul 27, 2022K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
Owens & Minor (O&M) Halyard, Inc.
FRG
May 5, 2022K221016Steriking Packaging for Medical Devices
Wipak OY, FI
FRG
Mar 14, 2022K213907CareGUARD Sterilization Wrap
Care Essentials Pty, Ltd., AU
FRG
Mar 10, 2022K220133Sterilization Wraps
Weihai Hongyu Nonwoven Fabric Products Co., Ltd., CN
FRG
Jan 23, 2022K210810Steiking Packaging for Medical Devices
Wipak OY, FI
FRG
Nov 1, 2021K212338SterileRight sterilization pouch and roll
Sterileright Packaging Mfg., Inc., TW
FRG
Oct 22, 2021K212198Tyvek(R) Roll with CI for STERLINKTM Sterilizer
Plasmapp Co,., Ltd., KR
FRG
May 19, 2021K202593Turbett Instrument Pod
Turbett Surgical, Inc.
FRG
Apr 23, 2021K202462SIGMA Sterilization Pouch and Roll
Sigma Medical Supplies Corporation, TW
FRG
Nov 12, 2020K200336Tyvek Sterilization Pouches with Chevron Seal
Andersen Sterilizers, Inc.
FRG
Nov 12, 2020K200335Sterisheet Sterilization Wrap
Andersen Sterilizers, Inc.
FRG
Apr 30, 2020K200240Turbett Instrument Pod
Turbett Surgical, Inc.
FRG
Apr 15, 2020K193561Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
Weihai Xingtai Packaging Products Co., Ltd., CN
FRG

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