7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018
FDA 510(k)
FDA Class 2
·Cardiovascular
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
FDA 510(k)
FDA Unclassified
·Unknown
VORICONAZOLE 1UG BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013
CURLIN INFUSION 4000CMS IV PUMP
FDA Adverse Event
Injury
·MOOG MEDICAL DEVICES GROUP·Product code FRN·January 31, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024