12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rulo Radiofrequency Lesion Probe
FDA 510(k)
FDA Class 2
·Neurology
Easy III
FDA UDI
CADWELL INDUSTRIES, INC.·00840067100738·Top Entry Remote Input Headbox; PSG
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804397·Cottle Periosteal Elevator, Curved, 9mm Blade, ...
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029041949·2 Upper Bicuspid Extraction
POWER STANDING DANI
FDA 510(k)
FDA Class 2
·Physical Medicine
THE IC-PRO SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
I-STAT E3+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·March 31, 2020
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 21, 2014
DURAGEN DURAL GRAFT MATRIX
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORP.·Product code GXQ·June 21, 2013
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR·Product code FTL·July 18, 2011
AVAN REINF RING SS 48/58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 17, 2020