47 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFETYNET GUIDEWIRE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
OneFill
FDA UDI
US ENDODONTICS, LLC·00810047644576·Gutta percha plastic carrier obturator
Matira
FDA UDI
Kalitec Direct LLC·B073DRK010029·Drill Guide, Variable, Attached Handle
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0100290·Caddie Lid, MIS Rods and Caps
DENTURE BASE
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI0400290·DENTURE BASE DARK FIBERED 7 LB
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935106296·
BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·September 16, 2024
HOME HEALTH MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
FDA 510(k)
FDA Class 3
·Cardiovascular
BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·September 24, 2024
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·November 28, 2022
BD VACUTAINER® ONE USE HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 8, 2024
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·EUCLID SYSTEMS ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear