10 results
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25ms
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Sources: EU EUDAMED, US FDA
CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
MEAS 4400 Series Temperature Probe
FDA UDI
MEASUREMENT SPECIALTIES, INC.·H29744640·Foley Catheter Temperature Probe, 14 FR
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471159495·SAGITTAL BLADE - DE SOUTTER STANDARD 13 x 25 x ...
KARL STORZ NAV1 Electromagnetic Navigation System
FDA 510(k)
FDA Class 2
·Neurology
ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 28, 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