13 results
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25ms
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Sources: EU EUDAMED, US FDA
PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
K2-HF DENTINE, D-B2, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38621070·
EndoEssentials™ Gutta Percha Points L - Non-Standard Accessory
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172014915·Polymer-based endodontic gutta percha
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177393·Modular Trial, 14 x 13 x 7mm, 10 Deg Lordosis
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862107180·Standard Band, Tooth 45/35, Size 7/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862107220·Standard Band, Tooth 45/35, Size 7/Roth 22
TPH Spectra+ Universal Composite Restorative
FDA 510(k)
FDA Class 2
·Dental
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
FDA 510(k)
FDA Class 2
·Radiology
ATTAIN ABILITY PLUS
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 10, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2010
SINGLE EXTENSION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 29, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
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