8 results
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17ms
·
Sources: EU EUDAMED, US FDA
THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E
FDA 510(k)
FDA Class 2
·Microbiology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984123·anteriors; shade A3; mould 92 S
VERICORD S3
FDA 510(k)
FDA Class 2
·Radiology
AMOS BOY LIFT CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 28, 2013
FREESTYLE
FDA Adverse Event
Malfunction
·Product code LFR·August 6, 2014
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 10, 2011
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026