50 results · 34ms · Sources: EU EUDAMED, US FDA

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NewTom 5G XL

FDA 510(k)
FDA Class 2 ·Radiology

Vanguard® Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304271173·

Vanguard Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304465947·

BRIVO XR385

FDA 510(k)
FDA Class 2 ·Radiology

CABLE, TRANSDUCER, MODEL 2400GN

FDA 510(k)
FDA Class 2 ·Cardiovascular

VANGUARD DCM CR TIBIAL BEARING

FDA Adverse Event
Malfunction ·BIOMET, INC.·Product code JWH·May 20, 2008

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2020

INSPIRE 8F M

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 3, 2024

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

SYNCHRON® LX20 PRO ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 28, 2011

ARCOM SERIES A STANDARD PATELLA

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 20, 2018

INSPIRE 8F M

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024

INSPIRE OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026

INSPIRE OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026

Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448.

FDA Recall
Terminated ·Biomet, Inc.·Product code JWH·February 12, 2008

INSPIRE 8F

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025

INSPIRE 8F

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025

INSPIRE OXYGENATOR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·December 11, 2025

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 20, 2021