64 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code ELW·February 4, 2013
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code ELW·February 4, 2013
Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·February 20, 2013
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·February 20, 2013
CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds.
FDA Recall
Terminated
·Pharmaplast S.A.E. Free Zone Factory POB 37 Amria Free Zone Kafr El Zayat, Gharbia Egypt·Product code KGX·February 21, 2011
BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
FDA Recall
Terminated
·Abiomed, Inc.·Product code DSQ·August 19, 2003
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
FDA Recall
Terminated
·Polymer Technology Systems·Product code LCP·December 2, 2016
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018
Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
FDA Enforcement
Class II
·Terminated·Polymer Technology Systems·December 25, 2019
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm.
FDA Recall
Terminated
·Abbott Vascular·Product code PNY·April 26, 2017
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm.
FDA Enforcement
Class I
·Terminated·Abbott Vascular·June 7, 2017
CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code GEH·July 15, 2020
CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·September 30, 2020
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
FDA Recall
Terminated
·ASO, LLC·Product code MGO·July 26, 2013
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
FDA Enforcement
Class II
·Terminated·ASO, LLC·August 14, 2013
CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as the disinfecting agent. 12 Fl. Oz (355 ML). [OTC] Item Number: 191648
FDA Recall
Terminated
·Product code LYL·November 20, 2003
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Recall
Terminated
·Illumina Inc·Product code PFS·November 6, 2014