8 results
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20ms
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Sources: EU EUDAMED, US FDA
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981669·anteriors; shade D3 light; mould UL2
IMPROVED COMFORT-FIT NIGHTGUARD
FDA 510(k)
FDA Unclassified
·Unknown
ConvertX Biliary Stent System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 27, 2013
STRAIGHT RASP HANDLES
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHAH·Product code LXH·January 12, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 5, 2014
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016