43 results · 23ms · Sources: EU EUDAMED, US FDA

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Clarius Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

BIOMET HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304255319·

MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

ALEUTIAN SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 3, 2026

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·July 15, 2011

XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·June 11, 2013

NXSTAGE SYSTEM ONE

FDA Adverse Event
Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·September 16, 2008

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

KIT VERITOR FLU HOSPITAL 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·October 7, 2025

TERUMO RADIFOCUS GUIDE WIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 12, 2025

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 6, 2026