9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Visant Medical Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM
MR VESSELLQ XPRESS
FDA 510(k)
FDA Class 2
·Radiology
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
INRATIO
FDA Adverse Event
Injury
·BIOSITE INCORPORATED·Product code JPA·February 2, 2010
SYNERGY
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 6, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 24, 2011
4000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 2, 2013
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