9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
Sharpsite®
FDA UDI
MEDTRONIC XOMED, INC.·00643169937390·ENDOSCOPE 1880155 SHARPSITE 4MM/45DEG
SHARPSITE®
FDA UDI
MEDTRONIC XOMED, INC.·00681490046985·ENDOSCOPE 1880155 SHARPSITE 4MM/45DEG
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arm Type Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
INFINITI VISION SYSTEMS OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 15, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 19, 2012
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