31 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hearing Healthcare Pro
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
FDA 510(k)
FDA Class 2
·Radiology
NMI PICC MAXIMAL BARRIER NURSING KITS
FDA 510(k)
FDA Class 2
·General Hospital
REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 11, 2022
THREADED GLENOID BASEPLATE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 5, 2025
PROPLEGE CORONARY SINUS DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·June 14, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 1, 2011
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2014
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
FDA Enforcement
Class II
·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·June 12, 2019
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·June 5, 2020
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 26, 2023
REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSD·July 15, 2022
REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSD·April 26, 2023
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 21, 2025
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 28, 2021
REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSD·May 5, 2022
REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 42XØ27
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSD·October 14, 2021
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 16, 2025
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 28, 2024
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 21, 2023