30 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LEONE SPA
FDA UDI
LEONE SPA·08033707011989·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 2
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180522479·PLIF Cup Curette, Serrated, 45° Up, Size 2
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
FDA 510(k)
FDA Class 2
·Immunology
6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
FDA 510(k)
FDA Class 2
·General Hospital
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
TORNIER SIMPLICITI NUCLEUS SIZE 2
FDA Adverse Event
Injury
·TORNIER INC·Product code PKC·October 20, 2025
TORNIER SIMPLICITI NUCLEUS SIZE 2
FDA Adverse Event
Injury
·TORNIER INC·Product code PKC·June 10, 2025
ABUTMENT, PATIENT SPECIFIC, TITANIUM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·June 26, 2017
TORNIER SIMPLICITI NUCLEUS SIZE 2
FDA Adverse Event
Injury
·TORNIER INC·Product code PKC·February 24, 2026
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·October 6, 2014
ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·June 3, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·June 2, 2011
TORNIER SIMPLICITI NUCLEUS SIZE 1
FDA Adverse Event
Injury
·TORNIER INC·Product code PKC·April 16, 2026
TORNIER SIMPLICITI NUCLEUS SIZE 2
FDA Adverse Event
Injury
·TORNIER INC·Product code PKC·March 3, 2026
TORNIER SIMPLICITI NUCLEUS SIZE 2
FDA Adverse Event
Injury
·TORNIER INC·Product code PKC·March 3, 2026
TORNIER SIMPLICITI NUCLEUS SIZE 1
FDA Adverse Event
Injury
·TORNIER INC·Product code PKC·January 2, 2025
TORNIER SIMPLICITI NUCLEUS SIZE 1
FDA Adverse Event
Injury
·TORNIER INC·Product code PKC·January 2, 2025
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020