10 results
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24ms
·
Sources: EU EUDAMED, US FDA
EMCO WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
HomeSafe Standard Slimline Personal Help Wriststrap
FDA UDI
Lifeline Systems Company·00884838071827·SE324G Personal Help Button/Wriststrap
ANIMAL SERUM PRODUCTS
FDA 510(k)
FDA Class 1
·Hematology
AEQUALIS REVERSED SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
AEQ REVERSED II GLENOID SPHERE D.42MM CENTER D 25MMBASEPLATE
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code PHX·October 2, 2024
ACCOLADE PLUS TMZF HIP STEM #4
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·May 30, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 20, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·June 11, 2015
AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 7, 2025
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