11 results
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34ms
·
Sources: EU EUDAMED, US FDA
ANTICONVULSANT CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Curian Campy
FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102387·Curian Campy, for use with the Curian Analyzer,...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110584·COAXIAL IRRIGAT-ASPIRAT TIP 45 DEG ASP
Ortho Specialties
FDA UDI
Young Innovations, Inc.·00843471187081·Anatomical Molar Bands, Lower Left 2Nd Molars, ...
CLINICARD PHOSPHORUS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Instrument kits
FDA 510(k)
FDA Class 2
·General Hospital
MULTISPOT HIV-1/HIV-2 RAPID TEST KIT
FDA Adverse Event
BIO-RAD LABORATORIES·Product code MZF·April 7, 2014
DHS/DCS GUIDE SHAFT WITH FLATS
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code HSB·September 20, 2012
TALENT THORACIC STENT GRAFT SYSTEM - COILTRAC
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 15, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019