47 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
FDA 510(k)
FDA Class 2
·Radiology
Zavation
FDA UDI
Zavation LLC·00842166146532·eZspand PLIF/T-PLIF 11x32x10°, 10.5-15mm
Zavation
FDA UDI
Zavation LLC·00842166146419·eZspand PLIF/T-PLIF 11x32x10°, 8.5-13mm
ASP
FDA UDI
SEDATELEC·03760262493497·The ASP Multi, Semi-Permanent Needle, is an ori...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK113201·DD tempMED are pre-colored dental milling blank...
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104325·Rod Straight 5.5 x 100mm
TRUWAVE
FDA 510(k)
FDA Class 2
·Neurology
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
UniSyn Hip System
FDA UDI
Shalby Advanced Technologies, Inc.·00840286835732·Stem, Bowed, Fluted, Cementless, 13mm, 210mm
Trulink
FDA UDI
Statcorp Medical·10841522123443·BP CUFF,TL VINYL,1T,SMALL ADULT,18-26CM,5/BG
UniSyn® Hip System
FDA UDI
CONSENSUS ORTHOPEDICS, INC.·00844588009051·Stem, Bowed, Fluted, Cementless
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 27, 2024
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 29, 2025
EMERGE?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 19, 2026
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 8, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 30, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·January 30, 2026
INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 2, 2016
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·October 28, 2025