9 results
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34ms
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Sources: EU EUDAMED, US FDA
HAIR TRANSPLANT PUNCH, MULTIPLH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Epilaser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
FDA 510(k)
FDA Class 2
·Cardiovascular
POLISHED FINNED TIB TRAY 67MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRO·March 28, 2019
SOFTCLIX LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 13, 2007
VERIFLEX¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code MAF·October 3, 2012
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·December 18, 2013
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017