19 results · 24ms · Sources: EU EUDAMED, US FDA

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MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

eNAT molecular collection and preservation medium

FDA 510(k)
FDA Class 2 ·Microbiology

SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025

LYNX ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025

LYNX ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·June 14, 2024

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·July 22, 2024

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 10, 2025

PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 12, 2008

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 1, 2011

UNIVERSAL BLOCK TRAY

FDA Adverse Event
Malfunction ·INTEGRA PAIN MANAGEMENT·Product code FMF·July 15, 2013

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022