10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HCI MECONIUM ASPIRATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
LEONE SPA
FDA UDI
LEONE SPA·08033707059028·DB TUBE EXTREMO NO-Ni 22 T-14 R+8 UR
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862132220·Standard Band, Tooth 45/35, Size 32/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862132180·Standard Band, Tooth 45/35, Size 32/Roth 18
105MM SPOT FILM CAMERA
FDA 510(k)
FDA Class 2
·Radiology
AVS PL PEEK SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·June 10, 2014
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 8, 2010
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·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