50 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Latex Dental Dams labeled as Non-Latex Dental Dams
FDA Enforcement
Class II
·Terminated·Coltene Whaledent Inc·August 13, 2014
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
FDA Enforcement
Class II
·Terminated·Remel Inc·December 25, 2013
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·March 12, 2014
Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
MAMMOGRAPHY
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·August 24, 2016
PEDIATRIC KIDNEY BIOPSY TRAY
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·August 24, 2016
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·August 24, 2016
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·August 24, 2016
COACH¿ Self-Adhering Sports Wrap (size: 2in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
COACH¿ Self-Adhering Sports Wrap (size: 3in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·February 5, 2020
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
FDA Enforcement
Class II
·Terminated·Fisher Diagnostics·August 2, 2017