633 results · 24ms · Sources: EU EUDAMED, 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