13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Codman Electrosurgical Generator, Foot Pedal
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271487·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304466272·
K083526
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·May 7, 2018
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code CBK·July 20, 2021
TOTAL KNEE REPLACEMENT CEMENT KLASSIC TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·TOTAL JOINT ORTHOPEDICS, INC.·Product code JWH·August 18, 2020
TRILOGY 100 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·December 19, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 18, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2011
ONE TOUCH LANCING DEVICE
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 13, 2022