10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707058991·DB TUBE EXTREMO NO-Ni 22 T-10 R+8 UL
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862123220·Standard Band, Tooth 45/35, Size 23/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862123180·Standard Band, Tooth 45/35, Size 23/Roth 18
MONOSPHERICAL SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·November 29, 2012
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