10 results
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18ms
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Sources: EU EUDAMED, US FDA
S-CAL HEMATOLOGY CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
LEONE SPA
FDA UDI
LEONE SPA·08033707058984·DB TUBE EXTREMO NO-Ni 22 T-10 R+8 UR
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862122220·Standard Band, Tooth 45/35, Size 22/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862122180·Standard Band, Tooth 45/35, Size 22/Roth 18
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLIRANS TH13 HOLLOW FIBER DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLEXTEND
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014
MBT REVISION CEM TIB TRAY SZ 3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·December 7, 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