12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036029692·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776364137·Oral Upper Molar Forcep,
NGB-005 Needle-guided Bracket
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904001685·
ADVIA RETIC PLUS
FDA 510(k)
FDA Class 2
·Hematology
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·September 21, 2015
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 15, 2014
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code NIP·July 8, 2020
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code NIP·July 8, 2020
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code NIP·July 8, 2020