8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACTERA FEMORAL STARTER BROACH
FDA UDI
Conformis, Inc.·00810933031428·ACTERA FEMORAL STARTER BROACH
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
FDA 510(k)
FDA Class 2
·Neurology
AMISTEM H FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·April 15, 2013
NEXGEN LPS-FLEX GSF FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·April 26, 2011
ROTATABLE SNARE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FDI·July 22, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014