30 results · 24ms · 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.

PERICAN ULTRA

FDA 510(k)
FDA Class 2 ·Anesthesiology

KneeAlign 2

FDA UDI
Orthalign, Inc.·00858704006015·Reference Sensor 2

KneeAlign 2

FDA UDI
Orthalign, Inc.·00851977007925·Reference Sensor 5 Knee (RS5K)

K133532

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·February 2, 2021

VARIFLEX

FDA 510(k)
FDA Class 2 ·Dental

DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

REPLY

FDA Adverse Event
Injury ·SORIN GROUP ITALIA S.R.L.·Product code NVZ·May 24, 2013

UNKNOWN ZIMMER KNEE

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·June 16, 2011

BRAVO

FDA Adverse Event
Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·August 20, 2008

LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·August 24, 2016

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022

FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2019

GMK SPHERE FEMORAL COMPONENT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 11, 2020

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2020

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 13, 2020

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2019

3005180920-2018-00587

FDA Adverse Event
Injury ·July 31, 2018