16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
SANI CATCH BA
FDA 510(k)
FDA Class 1
·Microbiology
LONESTAR
FDA UDI
Orthofix US LLC·18257200090372·DIA 4.0MM RESCUE BONE SCREW - 14MM
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)
FDA 510(k)
FDA Class 2
·General Hospital
XPS® BUR - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·March 9, 2017
DRILL 3055601 SKEETER OTO-TOOL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC·Product code ERL·January 11, 2013
XPS® BUR - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·March 8, 2017
HARMONIC ACE ATT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 27, 2014
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 15, 2012
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 14, 2010
SILK SUTURE 30"(75CM) 2-0 BLK
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAP·April 8, 2021
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018