12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CardioConfirm
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517731562·CoRoent XL+, 14x18x65mm 15°
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1614650·16mm H x 14mm W x 65mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X161465120·16mm H x 14mm W x 65mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X16146580·16mm H x 14mm W x 65mm L x 8 degrees XLIF
KMI CEMENT RESTRICTOR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR
FDA 510(k)
FDA Class 2
·Dental
AMISTEM H, HA COATED STEM SIZE 7 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 2, 2016
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 14, 2011
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code LXH·September 11, 2008
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017