10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BruxZir® Esthetic NOW
FDA 510(k)
FDA Class 2
·Dental
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184690·Integra® Jarit® Smith-Petersen Gouge, Straight
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776408015·5mm 33cm S/A Tapered Micro Grasp 3mm tip Stainl...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250223200·ceraMotion® Zr Chroma Concept Liner 3, 20 g / d...
VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Facet-Link Stabilization Platform
FDA 510(k)
FDA Unclassified
·Unknown
ALARIS SECONDARY ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·November 6, 2014
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code DQY·September 15, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.
FDA Enforcement
Class II
·Ongoing·Preat Corp·August 28, 2024