45 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
FDA Recall
Terminated
·Sunstar Americas, Inc.·Product code NTO·May 21, 2021
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
FDA Enforcement
Class II
·Terminated·Sunstar Americas, Inc.·June 16, 2021
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KWT·June 5, 2017
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
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Recall
Terminated
·Teleflex Medical·Product code BTT·June 5, 2014
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
FDA Enforcement
Class II
·Terminated·Clinician's Choice Dental Products Inc.·May 25, 2022
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·January 10, 2018
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
FDA Enforcement
Class II
·Terminated·Water Pik, Inc.·August 15, 2018
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.
FDA Enforcement
Class II
·Terminated·TZ Medical Inc.·November 25, 2015
Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral rinse. Product Usage: The mouthpaste is used to clean teeth, gums, and the tongue.
FDA Enforcement
Class II
·Terminated·Sage Products Inc·August 14, 2019
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