8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Resonic Rapid Acoustic Pulse Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 25, 2023
WMT-TCP BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
Dentsply Sirona Universal Spray Glazes
FDA 510(k)
FDA Class 2
·Dental
PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 WIDE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDT·August 25, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·July 12, 2013
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024