105 results · 25ms · 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.

Aquilion Lightning, TSX-036A/1, V8.4

FDA 510(k)
FDA Class 2 ·Radiology

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695632·Dynamic Dental Implant Ø3.25mm L11.5mm

LEONE SPA

FDA UDI
LEONE SPA·08033707018063·CALIBRA 1ST MOLAR BANDS n.LL 19

3.3mm Locking Drill Guide

FDA UDI
Osteocentric Technologies, Inc.·00816950029509·3.3mm Locking Drill Guide

CARRARA VOLUMIA

FDA 510(k)
FDA Class 2 ·Dental

PASCAL STREAMLINE PHOTOCOAGULATOR

FDA 510(k)
FDA Class 2 ·Ophthalmic

INRATIO2 PT/INR PROFESSIONAL TEST STRIP

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 9, 2015

INRATIO2 PT/INR TEST STRIP

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code GJS·March 4, 2016

ID NOW COVID 19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 3, 2022

ID NOW COVID 19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 3, 2022

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 19, 2015

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

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx

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