7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MULTICORE HB; MULTICORE FLOW
FDA 510(k)
FDA Class 2
·Dental
Withings ECG App
FDA 510(k)
FDA Class 2
·Cardiovascular
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·December 17, 2010
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 17, 2014
PERI-LOC
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., ORTHOPAEDICS DIV.·Product code HRS·November 15, 2006
PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014