9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RICHARDS PORP
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221116192·3M™ Victory Series™ First Molar Bands, 952-481,...
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150669·K-WIRE - SINGLE TROCAR THREADED 2.4mm DIA x 200mm
DURAFORM Dural Graft Implant
FDA 510(k)
FDA Class 2
·Neurology
BD VIPER SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·February 9, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 7, 2011
LIGAMAX CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 23, 2014
BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 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