11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rodo Smilekey
FDA 510(k)
FDA Class 2
·Dental
BONASTENT® Tracheal/Bronchial
FDA UDI
Sewoon Medical Co., Ltd.·08806369469142·
Origin Broach
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039684·
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 31, 2024
EPIDUCER LEAD DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SWC/DWC WARMING CABINETS
FDA 510(k)
FDA Class 1
·Physical Medicine
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·September 9, 2022
TENDRIL STS
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 17, 2014
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
FDA Enforcement
Class II
·Completed·Vyaire Medical·December 13, 2023