11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FILTER UNIT, SINGLE USE
FDA 510(k)
FDA Class 2
·General Hospital
ALIF
FDA UDI
Nuvasive, Inc.·00887517626752·ALIF Interfixated Inserter, Antero 34 UP
BD Prevue II Peripheral Vascular Access System
FDA UDI
Bard Access Systems, Inc.·00801741214950·BD Prevue II Traditional Probe
STAPLIZER
FDA UDI
Conmed Corporation·10845854015575·STAPLIZER BONE STAPLE CARTRIDGE, 7 X 7 MM
Single Use Arthroscopic Electrode (with Pencil)
FDA 510(k)
FDA Class 2
·Orthopedic
SPONGE AND GAUZE FORCEP PART #S-417-9
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
XLD 110V L.A. REF
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 18, 2014
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 29, 2007
RENEGADE¿ STC 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code DQO·October 3, 2012
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014