10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONESTEP CPR II MULTI-FUNCTION ELECTRODE
FDA 510(k)
FDA Class 3
·Cardiovascular
AGXO
FDA UDI
Oticon A/S·05707131262448·H100, RITE 312 WL SIL AGXO
PHYSIOLOGICAL MONITOR, PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·October 1, 2014
EXCLAIM 8
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013
STRATA VALVE SMALL (CLINICAL)
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·June 15, 2011
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015