12 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINI 6800 DIGITAL MOBILE C-ARM
FDA 510(k)
FDA Class 2
·Radiology
Aspira Drainage Tray
FDA UDI
Bard Access Systems, Inc.·00801741045073·Aspira Pleural Drainage Insertion Tray
Aspira®
FDA UDI
Merit Medical Systems, Inc.·00884450620649·
EASYRA GLU-H REAGENT, MODEL 10200
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Vantage Galan 3T, MRT-3020, V6.0
FDA 510(k)
FDA Class 2
·Radiology
PERMACOL 10X15 1.5MM
FDA Adverse Event
Death
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 4, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·February 15, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·June 21, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code PNG·April 22, 2023
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024