15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
FDA 510(k)
FDA Class 3
·Orthopedic
Thomas spanner key
FDA UDI
Cendres+Métaux SA·07640166511861·Thomas spanner key
Orthonol
FDA UDI
Rmo, Inc.·00885797016188·ORTHONOL(R) PREFORMED NATURAL ARCH MN .018
Thermaloy
FDA UDI
Rmo, Inc.·00885797021205·THERMALOY PLUS PREFORMED EXPANDED ARCH MX/MN .0...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697780·Titanium Base Abutment Round, Int. Hex. NP L6m...
AutoPulse Battery
FDA UDI
Zoll Circulation, Inc.·00849111002141·Box containing Nickel-metal Hydride (NiMH) batt...
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 9, 2022
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
FDA 510(k)
FDA Class 2
·Radiology
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
FDA 510(k)
FDA Class 2
·Orthopedic
ICON 25HCG
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JHI·February 14, 2011
CONFIDA BRECKER CURVE GUIDEWIRE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DQX·June 5, 2025
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 22, 2013
POLAR CATH
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code MAV·June 27, 2008
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·April 27, 2011
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