12 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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eego amplifiers
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100851·MCNEILL GLOBAL FIXATION RING MEDIUM
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
THERATRODE
FDA 510(k)
FDA Class 2
·Neurology
BD INTIMA-II IV CATHETER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·May 10, 2023
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·June 5, 2013
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 24, 2011
INFANT EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·September 19, 2008
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 9, 2023
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·May 10, 2023
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016