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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
Jan 24, 2020K192641Gemini Titan Sterilization Wrap
Medline Industries, Inc.
FRG
Oct 10, 2019K192147Halyard ONE-STEP* Sterilization Wrap
Owens & Minor (O&M) Halyard, Inc.
FRG
Oct 10, 2019K182184Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and S
Mdk (Shanghai) Medical Packing Co., Ltd., CN
FRG
Aug 19, 2019K183356Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
Weihai Xingtai Packaging Products Co., Ltd., CN
FRG
Jul 9, 2019K181957Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll
Tianchang Jiarui Packaging Material Co., Ltd., CN
FRG
Jun 11, 2019K182656JAMBRO Single Core A Sterilization wrap
Jiangsu Zhande Medical Supplies Co., Ltd., CN
FRG
Mar 22, 2019K181959HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
Owens & Minor Halyard, Inc.
FRG
Mar 1, 2019K183401Vis-U-All Low Temperature Sterilization Pouch/Tubing
STERIS Corporation
FRG
Jan 3, 2019K183297Vis-U-All Low Temperature Sterilization Pouch/Tubing
STERIS Corporation
FRG
Jan 3, 2019K180139Safe Secure Sterilization Pouches and Rolls
Safe Secure Packing Co., Ltd., CN
FRG
Dec 11, 2018K181174Cardinal Health Sterilization Wrap
Cardinal Health200, LLC
FRG
Aug 3, 2018K172280BH Sterilization Pouch
Bh Medical Products Co., Ltd., CN
FRG
Jun 6, 2018K180672Sterilization Pouch/Roll Made with Tyvek
Sigma Medical Supplies Corporation, TW
FRG
Jun 5, 2018K180661SIGMA Sterilization Pouch and Roll
Sigma Medical Supplies Corp., TW
FRG
Feb 9, 2018K172749Vis-U-All Low Temperature Sterilization Pouch/Tubing
STERIS Corporation
FRG
Nov 1, 2017K170437Sterisheet Sterilization Wrap
Andersen Sterilizers, Inc.
FRG
Oct 27, 2017K170429Tyvek Sterilization Pouches with Chevron Seal
Andersen Sterilizers, Inc.
FRG
Oct 13, 2017K162362PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
Pms Tibbi Cihazlar Teknolojisi San VE Tic AS, TR
FRG
Aug 25, 2017K172207Standard Supreme Sterilization Wrapper
Standard Textile Co., Inc.
FRG
Jun 29, 2017K171533Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
Ahlstrom Nonwovens, LLC
FRG
Jun 23, 2017K162993Gemini Sterilization Wrap
Medline Industries, Inc.
FRG
Apr 28, 2017K162258Self Sealing Sterilization Pouches
Tianchang Jiarui Packaging Material Co., Ltd., CN
FRG
Apr 20, 2017K161910Cardinal Health Sterilization Wrap
Cardinal Health200, LLC
FRG
Feb 10, 2017K161415SteriTite Containers System & MediTray Products
Case Medical, Inc.
FRG
Nov 18, 2016K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti, TR
FRG
Nov 4, 2016K162162Barrier Supreme Sterilization Wrapper
Standard Textile Co., Inc.
FRG
Aug 4, 2016K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
Safe Secure Packaging Co., Ltd., CN
FRG
Jul 27, 2016K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
Ahlstrom Nonwovens, LLC
FRG
Jul 22, 2016K160908Vis-U-All Low Temperature Sterilization Pouch/Tubing
STERIS Corporation
FRG
Jul 7, 2016K152564Gemini Sterilization Wrap
Medline Industries, Inc.
FRG
Jun 1, 2016K152458Gemini Bonded Sterilization Wrap
Medline Industries, Inc.
FRG
Jan 15, 2016K152669PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std, TR
FRG
Jan 14, 2016K153025Turbett Surgical Container
Turbett Surgical, LLC
FRG
Dec 21, 2015K151445Cardinal Health Sterilization Wrap
Cardinal Health200, LLC
FRG
Dec 17, 2015K152291Sterisheet Sterilization Wrap
Andersen Sterilizers, Inc.
FRG
Nov 20, 2015K150698Gemini Sterilization Wrap
Medline Industries, Inc.
FRG
Nov 18, 2015K152058Tyvek Sterilization Pouches with Chevron Seal
Andersen Sterilizers, Inc.
FRG
Oct 30, 2015K151788Cardinal Health Sterilization Wrap
Cardinal Health200, LLC
FRG
Oct 29, 2015K143117Wire Sterilization Package with Indicators
American Orthodontics
FRG
Sep 9, 2015K143637U&U Sterilization Pouch and Roll
U&U Medical Technology Co, Ltd., CN
FRG
May 7, 2015K143147Gemini Bonded Sterilization Wrap
Medline Industries, Inc.
FRG
Apr 3, 2015K143053KIMGUARD ONE-STEP Sterilization Wrap
Kimberly-Clark Health Care
FRG
Apr 2, 2015K141826FLASHPAK STERILIZATION CONTAINER SYSTEM
Symmetry Medical Inc- Manchester
FRG
Mar 11, 2015K133838STERILIZATION POUCH/ROLL MADE WITH TYVEK
Sigma Medical Supplies Corp., TW
FRG
Mar 9, 2015K142782KIMGUARD ONE-STEP Sterilization Wrap
Kimberly-Clark Health Care
FRG
Dec 19, 2014K141693Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
Advanced Sterilization Products
FRG
Dec 18, 2014K141712KIMGUARD ONE STEP STERILIZATION WRAP
Halyard Health
FRG
Dec 3, 2014K141412STERILUCENT SELF-SEAL STERILIZATION POUCH
Gs Medical Packaging, Inc.
FRG
Nov 10, 2014K140963KIMGUARD SMART-FOLD STERILIZATION WRAP
Kimberly-Clark Corp.
FRG
Aug 7, 2014K141612KIMGUARD ONE-STEP STERILIZATION WRAP
Kimberly-Clark Health Care
FRG

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