8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ProLift Expandable System
FDA 510(k)
FDA Class 2
·Orthopedic
CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
FDA 510(k)
FDA Class 2
·General Hospital
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 21, 2014
NARKOMED
FDA Adverse Event
Death
·DRAEGER MEDICAL SYSTEMS, INC. (PNC)·Product code BSZ·July 28, 2011
SYNFRAME-EXTENSION W/JOINT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 26, 2013
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024