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

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VERTEX THERMOSENS RIGID

FDA 510(k)
FDA Class 2 ·Dental

General Instrument

FDA UDI
ALPHATEC SPINE, INC.·00840180515242·Zodiac Pedicle Marker, Cylinder

VOYAGER PERITONEAL DIALYSIS SYSTEM

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

VARISOURCE BREAST TEMPLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

EMERGE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 27, 2024

EMERGE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 29, 2025

EMERGE?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 19, 2026

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 4, 2021

EMERGE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 8, 2026

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 30, 2026

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·January 30, 2026

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 3, 2021

EMERGE?

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

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 26, 2026

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 21, 2026

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 21, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

NEOPUFF INFANT RESUSCITATOR

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTL·August 4, 2008

M2A MAGNUM MODULAR HEAD 46MM HEAD DIAMETER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·November 29, 2016

EMERGE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026