9 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem
FDA 510(k)
FDA Class 2
·Orthopedic
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ADHESIVE 14
FDA 510(k)
FDA Class 2
·Dental
SYRINGE 3ML LL 200 S/C
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·May 16, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
GLIDESCOPE GVL 4
FDA Adverse Event
Death
·VERATHON MEDICAL·Product code CCW·August 24, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 12, 2013
3 ML BD LUER-LOK LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·September 30, 2019
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018