26 results · 22ms · 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.

PathBuilder Steerable Introducer

FDA 510(k)
FDA Class 2 ·Cardiovascular

Portex

FDA UDI
ICU MEDICAL, INC.·10788942215306·

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07310K0115300·Needle, Trocar Stylet, Stainless Steel, Disposable

VERTRAN STANDING WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

BODYFIX SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·October 30, 2024

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021

BD PARADIGM LINK GLUCOSE MONITOR

FDA Adverse Event
Other ·NOVA BIOMEDICAL CORPORATION·Product code NBW·October 2, 2008

ACT 5 DIFF FIX

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GGK·August 5, 2011

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code MCX·July 8, 2013

MRHK TIB INS 13MM M/L M2/L2

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·April 28, 2026

AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·July 23, 2025

AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·October 29, 2024

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·April 8, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·April 9, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·February 11, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·March 31, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 27, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·February 11, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·February 11, 2025