7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KJ Mini Implant System
FDA 510(k)
FDA Class 2
·Dental
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
DIGITEK TITANIUM ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014
UHR BIPOLAR 26X45MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWL·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023