8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
RAPIDFLAP CRANIAL CLAMP
FDA 510(k)
FDA Class 2
·Neurology
Zavation
FDA UDI
Zavation LLC·00842166118386·Cervical Compressor, 3.5mm
Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
FDA 510(k)
FDA Class 2
·Cardiovascular
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·March 6, 2013
CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024