12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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5008X Hemodialysis System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Zimmer Patient-Specific Abutment, Internal Hex, Titanium
FDA 510(k)
FDA Class 2
·Dental
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BELLATEK® ABUTMENT TSV 3.5MM
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code NHA·February 5, 2021
IBP ELB INT. ULNA LRG RGT LNG STM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·June 24, 2016
ABUTMENT, PATIENT SPECIFIC, TITANIUM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·June 26, 2017
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020
OBGYN STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·August 22, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 23, 2013