9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCIMED ECMOTHERM(TM) HEAT EXCHANGER
FDA 510(k)
FDA Class 2
·Cardiovascular
Precept
FDA UDI
Nuvasive, Inc.·00887517426819·PRECEPT Screw, 4.5x60mm Fixed
VITEX P.D.A
FDA 510(k)
FDA Class 2
·Dental
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 19, 2014
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·October 19, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·December 22, 2012
G7 OSSEOTI MULTIHOLE 58MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 12, 2024
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020