13 results
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34ms
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Sources: EU EUDAMED, US FDA
INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860121220·Standard Band, Tooth 15-14/24-25, Size 21/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860121000·Standard Band, Tooth 15-14/24-25, Size 21
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860121180·Standard Band, Tooth 15-14/24-25, Size 21/Roth 18
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
FDA 510(k)
FDA Class 2
·Neurology
CorPath GRX System
FDA 510(k)
FDA Class 2
·Cardiovascular
NEUROMONITOR BASIC KIT
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code GWM·October 24, 2023
CAPSUREEPI
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
HS III PROXIMAL SEAL SYSTEM 4.3MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·November 21, 2012
DEBAKEY TANGENT OCCL CLMP 10
FDA Adverse Event
Malfunction
·J. JAMNER SURGICAL INSTRUMENTS, INC.·Product code DXC·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
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