9 results
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21ms
·
Sources: EU EUDAMED, US FDA
LACTATE DEHYDROGENASE (LD) PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641356·OPAQUE MATERNITY 20-30 MM HG KNEE HIGH ZIG ZAG ...
J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.
FDA 510(k)
FDA Class 2
·Immunology
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
SECURA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 29, 2012
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 6, 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