10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M Attest Hydrogen Peroxide Indicator Tape 1228
FDA 510(k)
FDA Class 2
·General Hospital
FASTIN ETHIBOND
FDA UDI
DEPUY MITEK, LLC·10886705007516·FASTIN ANCHOR Size 2 (5 metric) green ETHIBOND ...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM
OXTI INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
FDA 510(k)
FDA Class 2
·Cardiovascular
KS-NI2
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·November 3, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 24, 2011
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC·Product code GEI·July 2, 2013
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024