10 results · 18ms · 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.

LASER RESISTANT TRACHEAL TUBE (TENTATIVE)

FDA 510(k)
FDA Class 2 ·Anesthesiology

Stainless Steel Wire

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746050039·WIRE SS POSTED UNIV 019 X 025 26MM 10/PK

VASHE WOUND CLEANSING SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

Xpert Carba-R

FDA 510(k)
FDA Class 2 ·Microbiology

CAPSUREFIX

FDA Adverse Event
Injury ·MPRI·Product code DTB·June 10, 2014

PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2010

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 6, 2012

Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

FDA Enforcement
Class II ·Terminated·Alcon Research, LLC·October 21, 2020

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012