7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
FDA 510(k)
FDA Class 2
·Immunology
TRANS-CATHETER EXTRACTOR
FDA 510(k)
FDA Class 2
·General Hospital
Smart Stitching Software System, Image Processing, Radiological
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2014
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 25, 2013
T-MAX ACCESSORIES
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE·Product code HRX·January 18, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024