9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
UCS-2, ULTRASONIC CLEANING SOLUTION
FDA 510(k)
FDA Class 1
·General Hospital
EndoCure Model EUR078A
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROTECTA XT DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 8, 2010
S3 SIGNATURE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 2012
OXFORD UNI TIB BRG MED SZ4
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·December 7, 2023
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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