12 results
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19ms
·
Sources: EU EUDAMED, US FDA
FILTER SAMPLER BLOOD SERUM FILTER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ERA® Micro Ovd. Males White (5)
FDA UDI
STERNGOLD DENTAL LLC·00841549100796·Resilient semi-precision attachment. Attachmen...
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334012465·VanBuren Urethral Sound, Curved
AURADONICS
FDA UDI
AURADONICS INC.·00810033835292·LATEX ELASTICS 5/16" 6.5 oz. - AMBER, 10000 ea....
RD-3008
FDA 510(k)
FDA Class 2
·Dental
EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 7, 2017
COREVALVE REVALVING SYSTEM
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 7, 2017
HIRES 90K IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·March 24, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
PUMP MMT-722LNAS PRDGM INS SK EN ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·August 10, 2010
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Enforcement
Class II
·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025