16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEONICS X CEMENTED HIP STEM SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·December 9, 2015
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·January 8, 2016
SMITH & NEPHEW PEEK INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Care Orchestrator Essence
FDA 510(k)
FDA Class 2
·Anesthesiology
TIBIAL NAIL, STANDARD 10X390 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·March 17, 2010
XPS HANDPIECE - VISAO
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 2, 2021
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012
DRILL 3334800 VISAO 80K HANDPIECE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017
EXTRACT-HOLD-SLEEVE F/HIPPIN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·February 28, 2013
LIGHT SPEED 16 SLICE
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code JAK·July 8, 2014
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·February 2, 2011
Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·June 9, 2016