633 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nacera
FDA UDI
DOCERAM medical ceramics GmbH·EDMC3110WN87880·3Y-TZP-A zirconium dioxide, pre-sintered white-...
Nacera
FDA UDI
DOCERAM medical ceramics GmbH·EDMC3210WN87870·3Y-TZP zirconium dioxide, pre-sintered white-fi...
Nacera
FDA UDI
DOCERAM medical ceramics GmbH·EDMC3110WN87870·3Y-TZP-A zirconium dioxide, pre-sintered white-...
Nacera
FDA UDI
DOCERAM medical ceramics GmbH·EDMC3210WN87880·3Y-TZP zirconium dioxide, pre-sintered white-fi...
TENDRIL
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NVN·November 3, 2019
UNI GLENOID-PERIPHERAL LOCK SCRW
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code PHX·November 15, 2021
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·July 15, 2015
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.
FDA Recall
Terminated
·3M Company Health Care Business 3M Center·Product code EBF·June 15, 2015
MOLLRING CUTTER TRANSECTION DEVICE
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR·Product code DWX·February 29, 2012
ENDORE MOLLRING CUTTER TRASECTION DEVICE
FDA Adverse Event
Injury
·LEMAITRE VASCULAR, INC.·Product code DWX·May 14, 2021
MOLLRING CUTTER
FDA Adverse Event
Other
·LEMAITRE VASCULAR, INC.·Product code DWX·October 1, 2009
MOLLRING CUTTER
FDA Adverse Event
Other
·LEMAITRE VASCULAR·Product code DWX·November 13, 2008
HAWKONE LS PLUNGER
FDA Adverse Event
Malfunction
·MEDTRONIC VASCULAR·Product code DWX·October 16, 2020
FOGARTY ENDOHELIX REMOTE ENDARTERECTOMY
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR·Product code DWX·October 14, 2011
MOLLRING CUTTER TRANSECTION DEVICE
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR·Product code DWX·May 26, 2011
ENDORE MOLLRING CUTTER TRASECTION DEVICE
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code DWX·May 16, 2018
VALVUTOME
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS·Product code DWX·August 16, 2017
MOLLRING CUTTER
FDA Adverse Event
Other
·VASCULAR ARCHITECHS·Product code DWX·February 8, 2008
Stripper, Artery, Intraluminal
FDA classification
FDA Class 2
·Stripper, Artery, Intraluminal
DAX EYEWEAR
FDA registration
DAX EYEWEAR·1 product·🇺🇸 United States