48 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033879·Baltic Denture System BDLoad BDLoad ↓ Sw7 PLSEu...
TM2000, MODEL 1
FDA 510(k)
FDA Class 2
·Cardiovascular
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 3, 2013
CVC KIT: 2-LUMEN 7 FR X 8 (20 CM)
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQY·February 11, 2011
PUMP MMT-715LNAS PRDGM INS V2.1 SK EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·April 24, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 7, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 7, 2025