99 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CONSERVE BIO FOAM SHELL
FDA 510(k)
FDA Class 3
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040013·PrimaLIF Endplate Scraper, Pull
Matira
FDA UDI
Kalitec Direct LLC·B073DRK010029·Drill Guide, Variable, Attached Handle
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100090·Tray Insert 2, Cosmolock, Arcamed
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0100290·Caddie Lid, MIS Rods and Caps
Navagio
FDA UDI
Kalitec Direct LLC·B07330K1100090·Tray Insert
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K1100090·Tray Insert, Level II
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100090·Tray Insert
MEPILEX BORDER AG DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
HOME HEALTH MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BD QUINCKE SPINAL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code BSP·August 31, 2023
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
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
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