10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RIBBOND(TM)
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540364708·INSTRUMENT TRAY, ORTHOGNATHIC
16PW - Heat Stress Relief
FDA UDI
Certified Safety Manufacturing, Inc.·00766588130408·Heat Stress Relief - 16 Poly White
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130400·ROD REDUCER, AXIAL
CERAMIR CROWN & BRIDGE
FDA 510(k)
FDA Class 2
·Dental
LIGHT SABER INTRODUCER NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 14, 2014
CVC KIT: 2-LUMEN 8 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·June 11, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 14, 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