7 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SNUCONE Tissue Level Implant System
FDA 510(k)
FDA Class 2
·Dental
CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED)
FDA 510(k)
FDA Class 1
·General Hospital
BRIUS Clear Aligners
FDA 510(k)
FDA Class 2
·Dental
OSTEONICS UNIV. DISTAL SPACER
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·November 4, 2014
EXTENSION SET WITH ULTRASITE INJECTION AND SPIN-LOCK CONNECT
FDA Adverse Event
Malfunction
·B BRAUN·Product code FPA·August 16, 2011
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 12, 2013
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