12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I-FIX SYSTEM
FDA 510(k)
FDA Class 2
·Dental
K083526
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·May 7, 2018
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code CBK·July 20, 2021
MAGNETOM TRIO SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 29, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Death
·CPI - DEL CARIBE·Product code NVY·May 10, 2011
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 29, 2008
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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