12 results
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23ms
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Sources: EU EUDAMED, US FDA
ROPHAE DIAMOND KNIFE
FDA 510(k)
FDA Class 1
·Ophthalmic
HeartStart MRx monitor/defib
FDA UDI
Philips Medical Systems Hsg·00884838027961·
Scopis Hybrid Navigation System EM
FDA 510(k)
FDA Class 2
·Neurology
LAC-MAC INNERBLOC O.R. GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIRTUOSO II VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
CAPSURE Z
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·October 8, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
FDA Recall
Terminated
·Philips Medical Systems, Inc.·Product code MKJ·February 18, 2014
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·March 19, 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