13 results
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33ms
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Sources: EU EUDAMED, US FDA
ACROMED SPINAL SURGERY INSTRUMENTS
FDA 510(k)
FDA Class 1
·Orthopedic
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860131000·Standard Band, Tooth 15-14/24-25, Size 31
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860131180·Standard Band, Tooth 15-14/24-25, Size 31/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860131220·Standard Band, Tooth 15-14/24-25, Size 31/Roth 22
OEC Elite MiniView
FDA 510(k)
FDA Class 2
·Radiology
OSS-BODIES PROXIMAL TIBIAL SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·November 29, 2012
COOLPATH DUO 7F, 1304-CP2-7-1.5(5)2-L1-TE4BE1AB-CN
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL, IRVINE·Product code OAD·September 21, 2010
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·November 21, 2018
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