14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEOPLASTINE CI PLUS
FDA 510(k)
FDA Class 2
·Hematology
CLYDESDALE PTC™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169190818·CAGE 4922040 CDALE PTC 22MM 12 DEG 10X40
Clydesdale™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994972927·CAGE 2922040 CLYDESDALE 22 12DEG 10X40
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918180212·Gown_Standard_XXL_Non-Sterile_44ea/cs
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110997·DOUBLE PLASTIC STERILIZATION CASE
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111024·INSTRUMENT CADDY MEDIUM
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123854·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 100mm
LARGE AO COUPLING ASNIS III HALL FITTING
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 25, 2012
POWERED EMERGENCY VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
INVOTEC LARYNGEAL ELECTRODE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
E360 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·January 4, 2013
CONSULTA
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·December 13, 2010
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 9, 2014
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·October 13, 2021