7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE SUTURE REMOVAL KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
REVEAL DX
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·October 31, 2012
ESOPHY X2 -05
FDA Adverse Event
Injury
·REDMOND·Product code ODE·July 30, 2010
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