14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Genesys Spine Apache® Lateral Lumbar Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902757907·INSTRUMENT 8161404 4PRNG 4MM S STPL TRL
CoRoent
FDA UDI
Nuvasive, Inc.·00887517575708·CoRoent Ant TLIF Ti, 16x11x40mm 4°
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·20612479223718·Transducer Covers
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383539890·Gutta Percha Points is used to root canal filin...
HUIBAO BODY FAT SCALE
FDA 510(k)
FDA Class 2
·Cardiovascular
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
FDA 510(k)
FDA Unclassified
·Unknown
LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
FDA Adverse Event
Injury
·ZEST ANCHORS, INC.·Product code DZE·January 4, 2016
THROMBECTOMY
FDA Adverse Event
Injury
·SEE H.10·Product code NRY·July 30, 2018
STEALTH FIBRA
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES CORP·Product code DXC·June 4, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 13, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 12, 2008
ANATOMIC
FDA Adverse Event
Malfunction
·AMPLITUDE·Product code JWH·December 11, 2018
Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017