93 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code DBF·March 5, 2018
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A
FDA Recall
Open, Classified
·Ultradent Products, Inc.·Product code EBF·August 2, 2024
Artiste Flowable Part Number N28A, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EBF·October 22, 2010
PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32657, 10 PACK UNIDOSE PREMISE B3, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.
FDA Recall
Terminated
·3M Espe Dental Products·Product code EBF·February 12, 2007
NX3 Try-In Gel. The product is used as a tooth shade resin material.
FDA Recall
Terminated
·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·Product code EBF·September 13, 2013
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code DBF·October 9, 2012
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
FDA Recall
Terminated
·Sechrist Industries Inc·Product code CBF·August 28, 2008
ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories MPG·Product code DBF·June 6, 2006
PREMISE, PART NO. 32659, 10 PACK UNIDOSE PREMISE C1, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32652, 10 PACK UNIDOSE PREMISE A3, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE A4, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. Product Usage: The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include self-etch base liner, restorations of carious lesions, Class I, III and V cavity preparations and pitt and fissure sealant.
FDA Recall
Terminated
·Kerr Corporation·Product code EBF·August 19, 2010
Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL C3 N28N N28VP D2 N28R N28VR Universal Opaque N28XA N28VXA A0 N28XC N28VXC Incisal. The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EBF·March 3, 2011