8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAESTRO WRIST FRACTURE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
PerforMax
FDA UDI
Respironics, Inc.·00606959007697·PerforMax Mask with Entrainment Elbow, Leak 2, ...
VIP- VARIABLE INTENSITY POLYMERIZER
FDA 510(k)
FDA Class 2
·Dental
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
ALIGN R URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·April 24, 2013
COOK CUTTING LOOP
FDA Adverse Event
Injury
·COOK UROLOGICAL INC·Product code GEI·April 22, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 24, 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