8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XENON DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029196·Bipolar Head Trial, Size 43mm
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
FDA 510(k)
FDA Class 2
·Orthopedic
VASOVIEW 5 HARVESTING CANNULA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code FZP·October 30, 2007
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024