10 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ADENOLEX (R) LATEX AGGLUTINATION TEST
FDA 510(k)
FDA Class 1
·Microbiology
EndoEssentials™ Absorbent Paper Points 100 - #45 .06 Taper
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015233·Endodontic paper point
GOLD AIR, GOLD LIGHT
FDA 510(k)
FDA Class 1
·Dental
QBC CENTRIFUGAL HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 10, 2014
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 12, 2010
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 9, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025