30 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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