14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICRUS MICROCOIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032872·Baltic Denture System BDLoad Mn6 PLSEbim6DFm B1...
RESORBABLE SCREW ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
R&D PROJECT DW271#11A
FDA 510(k)
FDA Class 2
·Dental
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 3, 2013
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CGA·March 29, 2011
PEPGEN P-15 PUTTY
FDA Adverse Event
Injury
·DENTSPLY TULSA·Product code NPZ·April 23, 2008
HAHN IMPLANT HAHN TAPERED IMPLANT Ø3.5 X 11.5 MMX 11.5
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC·Product code DZE·April 18, 2025
HAHN IMPLANT HAHN TAPERED IMPLANT Ø3.5 X 11.5 MMX 11.5
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC·Product code DZE·April 18, 2025
BD NEXIVA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 3, 2023
BD NEXIVA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 3, 2023
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018