11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WILLI GELLER CREATION PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981490·anteriors; shade BL3; mould CS2
TILLMAN HIPSURFACE REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
SEAMLESS LATEX PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code LJH·February 27, 2013
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·January 11, 2011
ALARIS PCA MODULE
FDA Adverse Event
Injury
·CAREFUSION CORP.·Product code MEA·July 25, 2014
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020