13 results
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18ms
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Sources: EU EUDAMED, US FDA
HOLD-IT FRAMED ADHESIVE FILM
FDA 510(k)
FDA Class 1
·General Hospital
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981126896·Graft Tamp
Persona®
FDA UDI
Zimmer, Inc.·00889024552364·
Persona®
FDA UDI
Zimmer, Inc.·00889024552319·
Persona®
FDA UDI
Zimmer, Inc.·00889024552418·
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
NEXA COMPRESSION SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
VIVA QUAD XT
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
E500 VENTILATOR SYSTEM
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·November 21, 2012
TRUETRACK
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 17, 2010
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018
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