14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Madsen Zodiac
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776170592·CRILE CLAMP . DELICATE CURVED
17mm X 13.5mm X 7mm CERVICAL INTERBODY
FDA UDI
XENCO MEDICAL LLC·B064XM31617071·
Cervical Interbody 17mm x 13.5mm x 7mm
FDA UDI
XENCO MEDICAL LLC·B064XM21617071·
17mm X 13.5mm X 7mm CERVICAL INTERBODY
FDA UDI
XENCO MEDICAL LLC·B064XMPH31617071·
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 16, 2022
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
FDA 510(k)
FDA Class 3
·Cardiovascular
FULACCESS MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
ELECSYS TOTAL PSA IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MTF·November 19, 2018
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 25, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
BD¿ NEXIVA SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 21, 2019
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024