87 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLLAGEN RIBBON
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707008811·CALIBRA 1ST MOLAR BANDS n.UR 19
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05061075023214·KLEOS 2 PSL METAL HIGH TORQUE 022 UR3 HK PK5
OptiMesh Multiplanar Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7403120019·Stopped Pituitary Rongeur
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK1200110·Rod Gripper, 5.50mm Angled
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PASCAL STREAMLINE PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS EGFR MUTATION TEST
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 7, 2025
MR850
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 11, 2026
FISHER AND PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·September 22, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 6, 2024
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 10, 2024
FISHER AND PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 4, 2025
FISHER AND PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 19, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 10, 2024
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·Product code BTT·February 18, 2021
MR850
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·March 26, 2026
COBAS EGFR MUTATION TEST
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS, INC.·Product code OWD·January 29, 2014