11 results
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26ms
·
Sources: EU EUDAMED, US FDA
PHADEBAS & PHADEZYM RAST MIXED ALLERG
FDA 510(k)
FDA Class 2
·Immunology
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18310452·
Easter S.L Bracket, .022 Roth, LR5, w/o hook
FDA UDI
Astar Orthodontics Inc.·06941673516228·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471191839·SHAVER BLADE - MENISCUS CUTTER 4.5MM
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
AEROLET TOILET LIFT, MODEL AER-01
FDA 510(k)
FDA Class 2
·Physical Medicine
SERIES 7000 STANDARD TIBIA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 2, 2012
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 23, 2014
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code BTR·September 7, 2010
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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