22 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
FDA 510(k)
FDA Class 2
·Cardiovascular
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
ENHANCE HTF MEDIUM WITH HEPES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·August 26, 2024
REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 13, 2023
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 24, 2024
SHOULDER - TINBN COATING
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·July 30, 2025
SHOULDER - TINBN COATING
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·September 17, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 19, 2025
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BZD·July 22, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FMG·July 3, 2013
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·September 24, 2021
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 10, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 18, 2025
2.3MM X 12MM LOCKING CORTICAL SCREW
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code HWC·April 22, 2022
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·September 19, 2024
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PHX·May 26, 2026
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020