99 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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