11 results
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18ms
·
Sources: EU EUDAMED, US FDA
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028
FDA 510(k)
FDA Class 2
·Immunology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123847·K-WIRE - DOUBLE TROCAR 1.8mm DIA x 200mm
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Aquilion ONE (TSX-306A/3) V10.0
FDA 510(k)
FDA Class 2
·Radiology
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code FTL·February 28, 2013
ASKU
FDA Adverse Event
Injury
·MEDTRONIC MILACA INC.·Product code DTE·February 15, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026