9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982083·posteriors; shade C2; size L; lower jaw
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122833·K-WIRE - DOUBLE TROCAR 0.8mm DIA x 75mm
VAGATEX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Catalys Precision Laser System
FDA 510(k)
FDA Class 2
·Ophthalmic
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 5, 2014
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026