11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040064662·MOLAR BAND UR 1ST&2ND 40.5 (2)
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
FDA 510(k)
FDA Class 2
·Radiology
MODIFIED SINGLE AXLE TOTAL ELBOW
FDA 510(k)
FDA Class 2
·Orthopedic
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·April 16, 2013
U BY KOTEX CLICK TAMPONS
FDA Adverse Event
Malfunction
·AVENT S. DE R.L. DE C.V.·Product code HEB·April 8, 2011
CERNER MILLENIUM 2007.9 SOFTWARE: CPOE, EMAR
FDA Adverse Event
Other
·*·Product code LNX·June 12, 2008
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 9, 2025
EDWARDS LOCKING SYRINGE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·June 16, 2023
EDWARDS LOCKING SYRINGE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES LLC·Product code MAV·March 29, 2022
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