12 results · 21ms · 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.

ILUMIEN OPTIS

FDA 510(k)
FDA Class 2 ·Radiology

ArgenZ ST 98x14 ML C4

FDA UDI
ARGEN CORPORATION, THE·D818123369·Dental porcelain/ceramic restoration kit

ACCESS TOTAL T4 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VAULT ALIF SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NEXGEN PROVISIONAL ARTICULAR SURFACE

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 26, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

SENSITHERM PROBE

FDA Adverse Event
Injury ·FIAB S.P.A.·Product code FLL·July 10, 2023

VANGUARD MONO FINNED STM TIB 71X14

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·December 9, 2024

VANGUARD ROCC TIB BRG UHMWPE 60X10MM

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024