9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
-AMYLASE EPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306836077·Lowsley Tractor, Stright 28cm (11")
SUNTANNING DEVICE (SEPAR. FROM K812225)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
15W CERALAS D 1470NM DIODE LASER, MODEL D1470
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 18, 2014
VIRTUOSO VR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code LWS·October 26, 2010
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·December 20, 2012
Custom Breast Augmentation Pack, part number PSS2455(D
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017