24 results · 22ms · Sources: EU EUDAMED, US FDA

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chromID Strepto B agar

FDA 510(k)
FDA Class 1 ·Microbiology

CHROMID STREPTO B AGAR

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

CHROMID STREPTO B AGAR

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

Aquila Anterior Cervical Plate System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125806·

Pinehurst Anterior Cervical Plate System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215030742·

ATMOS E 201 THORAX AND ATMOS S 201 THORAX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CARDIOMEM CM 3000-12BT

FDA 510(k)
FDA Class 2 ·Cardiovascular

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·December 21, 2018

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·May 29, 2019

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024

1030489-2019-01511

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

POLYFORM SYNTHETIC MESH

FDA Adverse Event
Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·May 28, 2013

VIVA QUAD XT

FDA Adverse Event
Malfunction ·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014

1030489-2019-01423

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

KYPHX® HV-R¿ BONE CEMENT

FDA Adverse Event
Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·September 8, 2021

KYPHX® HV-R¿ BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 22, 2022

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·January 16, 2020