10 results
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18ms
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Sources: EU EUDAMED, US FDA
SET CANAL SEALER PASTE
FDA 510(k)
FDA Class 1
·Dental
ADVIA® Chemistry AAG a1-Acid Glycoprotein Reagents
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414590158·a1 Acid Glycoprotein - ADVIA Chem. - RGT - 2x1...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862129220·Standard Band, Tooth 45/35, Size 29/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862129180·Standard Band, Tooth 45/35, Size 29/Roth 18
P.0004 IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
RENASYS-G Gauze Dressing Kits with Soft Port
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROTECTA XT VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·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