9 results
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17ms
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Sources: EU EUDAMED, US FDA
100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2
FDA 510(k)
FDA Class 1
·Pathology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809643152·OPAQUE MATERNITY 20-30 MM HG THIGH HIGH ZIG ZAG...
IC-2 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DISPOSABLE TRACH T OXYGENATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 8, 2010
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·October 31, 2012
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