30 results · 21ms · Sources: EU EUDAMED, 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