9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ROTALEX
FDA 510(k)
FDA Class 1
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707032762·WEB 1ST MOLAR BANDS n.LR 29
CENTRIFICHEM BUN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Pledgeted COR-SUTURE QUICK LOAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014
EVA BAG-500ML
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SAO PAULO·Product code BTC·October 7, 2010
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·December 5, 2012
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012