8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
FDA 510(k)
FDA Class 2
·Neurology
NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT
FDA 510(k)
FDA Class 2
·Orthopedic
NutraStim Hair Laser Helmet
FDA 510(k)
FDA Class 2
·Physical Medicine
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 9, 2014
REPAIR CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·December 16, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·January 25, 2013
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024