9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CASCADIA™ Interbody System
FDA UDI
VB Spine LLC·10888857554566·Trial Size 14x18x7 mm, Convex
TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 22, 2013
ASKU
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·June 14, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·August 14, 2008
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 21, 2019
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.
FDA Enforcement
Class II
·Terminated·Philips North America Llc·May 18, 2022