9 results
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25ms
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Sources: EU EUDAMED, US FDA
NEW PODIATRY PRODUCTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813056325·WIRE NI-TEK UPPER .018X.025 PKG/10
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482125410·Symmetry® Retractor, Capsule, 3-Prong, Sharp, 2...
HEARTWAY LIGHTWEIGHT POWER CHAIR, P15
FDA 510(k)
FDA Class 2
·Physical Medicine
Silhouette Featherlift
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 3, 2012
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·November 13, 2007
CONTELLATION VISION SYSTEM
FDA Adverse Event
Injury
·ALCON MANUFAC- IRVINE TECHNOLOGY CENTER·Product code HQC·December 18, 2013
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
FDA Enforcement
Class II
·Terminated·CryoLife, Inc.·July 19, 2017