14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
FDA 510(k)
FDA Class 2
·General Hospital
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507638·
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113031·LOCATOR R-Tx Abutment for Large Internal Conica...
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481119545·LOCATOR F-Tx Abutment For Large Internal Conica...
OPTIDOS
FDA 510(k)
FDA Class 2
·Radiology
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 22, 2020
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·April 22, 2013
SURESTEP ONE STEP HCG PREGNANCY TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·April 14, 2011
M2A MAGNUM PF CUP 52MM X 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS INC.·Product code JDI·June 26, 2008
Voyager RX Coronary Dilatation Catheter
FDA Recall
Terminated
·Guidant Corporation Advanced CardiovascularSystem·Product code MAF·January 27, 2005
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018