13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hammerdesis Interphalangeal Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Unity Total Knee System
FDA UDI
CORIN LTD·05056139232565·Femoral Introducer
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Elos® Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
GLIDEWELL HT IMPLANT Ø3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 1, 2025
GLIDEWELL HT IMPLANT Ø3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC·Product code DZE·April 16, 2025
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·March 11, 2011
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 12, 2008
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 26, 2011
UNK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 17, 2013
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·October 25, 2021
AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015