14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SmartView 3D Option
FDA 510(k)
FDA Class 2
·Radiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111072154·SKLHN MAYO SCISS STR SERR 5.5"
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422
Ellis External Mini Fixator
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575229444·fixation pins without thread, smooth
BIOGRAPH MMR
FDA 510(k)
FDA Class 2
·Radiology
ADVANCED UROLOGICAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TI TRANSCONNECTOR 60MM
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code KWP·February 15, 2013
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 7, 2017
NA
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code NUJ·October 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 7, 2011
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Injury
·CONMED UTICA·Product code GEI·May 18, 2023
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·May 25, 2023
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023