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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 28, 2014K141071KIMGUARD ONE-STEP STERILIZATION WRAP
Kimberly-Clark Health Care
FRG
Jul 22, 2014K140487VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
STERIS Corporation
FRG
Feb 26, 2014K123162U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL
U&U Medical Technology Co, Ltd., CN
FRG
Dec 13, 2013K132060DURABLUE STERILIZATION WRAP
Cardinal Health-Medical Products and Services
FRG
Aug 20, 2013K113806KIMGUARD ONE STEP STERILIZATION WRAP
Kimberly-Clark Health Care
FRG
Jun 18, 2013K130927DURABLUE STERILIZATION WRAP
Cardinal Health200, LLC
FRG
Feb 28, 2013K123289DURABLUE STERILIZATION WRAP
Cardinal Health-Medical Products and Services
FRG
Jan 31, 2013K113353GEMINI STERILZATION WRAP
Medline Industries, Inc.
FRG
Jan 23, 2013K123857DURABLUE STERILIZATION WRAP
Cardinal Health200, LLC
FRG
Sep 26, 2012K122507DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION
Cardinal Health200, LLC
FRG
Aug 24, 2012K110954ARJORAD STERILE WRAP
Arjo Wiggins Medical, Inc.
FRG
Aug 8, 2012K113776FLASHPAK
Symmetry Medical
FRG
Jun 22, 2012K112805KIMGUARD ONE-STEP STERILIZATION WRAP
Kimberly-Clark Corp.
FRG
Jun 13, 2012K120658DURABLUE STERILIZATION WRAP
Cardinal Health200, LLC
FRG
Jun 1, 2012K120542CARDINAL HEALTH DURABLUE STERILIZATION WRAP
Cardinal Health-Medical Products and Services
FRG
Feb 7, 2012K112591SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS
Safe Secure Packaging Co., Ltd., CN
FRG
Jan 24, 2012K112904STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
Case Medical, Inc.
FRG
Jan 20, 2012K112918DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
Cardinal Health200, LLC
FRG
Jan 19, 2012K112300KIMGUARD SMART-FOLD* STERILIZATION WRAP
Kimberly-Clark Corp.
FRG
Oct 20, 2011K112283DURA BLUE STERILIZATION WRAP
Cardinal Health200, LLC
FRG
Oct 20, 2011K112211DURA BLUE STERILIZATION WRAP
Cardinal Health200, LLC
FRG
Aug 2, 2011K102158SIGMA STERILIZATION POUCH & ROLL
Sigma Medical Supplies Corp., TW
FRG
Jul 20, 2011K110867STERI-DENT, STERI-SURE
Cpac, Inc.
FRG
Jun 6, 2011K103210TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
Advanced Sterilization Products
FRG
Jan 14, 2011K10286484E SERIES SINGLE PLY WRAPPER
Lac Mac, Ltd.
FRG
Dec 22, 2010K102783HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
Hinson and Hale Medical Technologies, Inc.
FRG
Jul 27, 2010K093493AESCULAP STERILCONTAINER S
Aesculap, Inc.
FRG
May 11, 2010K093649AESCULAP STERILCONTAINER S
Aesculap
FRG
Feb 24, 2010K090068STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS
Case Medical, Inc.
FRG
Nov 2, 2009K092167KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600
Kimberly-Clark Corp.
FRG
Sep 3, 2009K091685KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600
Kimberly-Clark Corp.
FRG
May 1, 2009K082554KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
Kimberly-Clark Corp.
FRG
Mar 27, 2009K082177KIMGUARD ONE-STEP STERILIZATION WRAP
Kimberly-Clark Corp.
FRG
Dec 5, 2008K080558STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
Case Medical, Inc.
FRG
May 30, 2008K080198TSO3 OZONE STERILIZATION WRAP
Tso3, Inc.
FRG
Dec 27, 2007K071886SELF SEAL STERILIZATION POUCH
Shanghai Jianzhong Medical Packaging Co., Ltd., CN
FRG
Oct 16, 2007K071087VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
STERIS Corporation
FRG
Jun 8, 2007K062704STERILIZATION POUCH WITH INDICATORS
Winner Industries (Shenzhen) Co., Ltd.
FRG
Dec 5, 2006K062100ARJOWRAP 47/100 AND 47/88
Arjo Wiggins Medical, Inc.
FRG
Nov 17, 2006K062510AESCULAP STERILCONTAINER SYSTEM
Aesculap
FRG
Oct 16, 2006K052992CONMED LINVATEC INSTRUMENT STERILIZATION TRAY
Conmed Linvatec
FRG
Feb 27, 2006K052665GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES
Granton Medical , Ltd.
FRG
Feb 15, 2006K053389AESCULAP STERILCONTAINER SYSTEM
Aesculap, Inc.
FRG
Jun 3, 2005K041096WAGNER STERISET STERILIZATION CONTAINER
Wagner GmbH
FRG
Dec 13, 2004K041623REUSABLE STERILCONTAINER FILTER MODEL #JK090
Aesculap, Inc.
FRG
Dec 6, 2004K040865AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER
Aesculap
FRG
Nov 17, 2004K042580TIDI BRAND STERILIZATION WRAP
Banta Healthcare Group, Ltd.
FRG
Apr 16, 2004K040707PACKAGING TRAY AND COMPONENTS
Vygon Us, LLC
FRG
May 9, 2003K022978STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
Case Medical, Inc.
FRG
Apr 14, 2003K031022PROTEC-TOP, STERIDENT, BENTO
Ronpak, Inc.
FRG

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