8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPUS NAPA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FO41 BODY MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
BC 1206 IMPLANT - INSERT TYPE
FDA 510(k)
FDA Class 2
·Dental
SHELL POROUS WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·May 26, 2017
SOFTCLIX® PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·December 21, 2010
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 4, 2013
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 15, 2014
***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***BIOMET 3i Dental lberica S.L.WTC Almeda Park, Ed, 1 Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain***Phone +34 934-705-500; Fax +34 933-717-849. Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code O-FY·March 10, 2011