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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

NOxBOXi Nitric Oxide Delivery System

FDA 510(k)
FDA Class 2 ·Anesthesiology

MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OPAL BAND CEMENT

FDA 510(k)
FDA Class 2 ·Dental

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 28, 2026

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 14, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·July 22, 2011

HEARTWARE® VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Malfunction ·HEARTWARE, INC·Product code DSQ·October 23, 2015

LINER: MPACT FLAT PE HC LINER 36/E

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·May 27, 2021

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 20, 2025

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·May 9, 2025

TRUWAVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2023

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·August 21, 2024

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 17, 2025

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025

STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 10

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 15, 2021

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025

MPACT 3D METAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·May 29, 2026