12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PROSOUND F75 ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·HITACHI ALOKA MEDICAL, LTD·Product code GXX·July 16, 2014
MLX
FDA UDI
Nuvasive, Inc.·00887517268945·MLX, 12x38x28mm 8°
MLX
FDA UDI
Nuvasive, Inc.·00887517266026·MLX, 12x38x28mm 4°
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
FDA 510(k)
FDA Class 2
·Immunology
BILI-THERAPY SPOT TYPE
FDA 510(k)
FDA Class 2
·General Hospital
HEMOCONCENTRATOR BC 20 PLUS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016
ARTEGRAFT AG640
FDA Adverse Event
Malfunction
·ARTEGRAFT, INC.·Product code LXA·May 15, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 26, 2014
ENPULSE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·June 14, 2011
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023