10 results
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18ms
·
Sources: EU EUDAMED, US FDA
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