16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ENZYMUN-TEST HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
K2-HF DENTINE, D-B3, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38621080·
EndoEssentials™ Gutta Percha Points XL - Non-Standard Accessory
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172014922·Polymer-based endodontic gutta percha
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177409·Modular Trial, 14 x 13 x 8mm, 10 Deg Lordosis
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862108180·Standard Band, Tooth 45/35, Size 8/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862108220·Standard Band, Tooth 45/35, Size 8/Roth 22
COMCASET SAFETY IV CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
Pressio 2 ICP Monitoring System
FDA 510(k)
FDA Class 2
·Neurology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 7, 2012
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Death
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
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