21 results · 25ms · Sources: EU EUDAMED, US FDA

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TRAUS ENDO

FDA 510(k)
FDA Class 1 ·Dental

IDEAL IQ SOFTWARE OPTION

FDA 510(k)
FDA Class 2 ·Radiology

RESOFIX BIOABSORBABLE EXPANSION BOLT

FDA 510(k)
FDA Class 2 ·Orthopedic

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·April 13, 2006

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019

ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 3, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·September 27, 2014

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·June 29, 2011

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

STAR S4 IR

FDA Adverse Event
Injury ·AMO MANUFACTURING USA, LLC·Product code LZS·May 4, 2021

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024