193 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
FDA 510(k)
FDA Class 2
·Orthopedic
GE VIVID 3 EXPERT; GE VIVID 3 PRO
FDA 510(k)
FDA Class 2
·Radiology
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VPV SYSTEM
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF MEDOS·Product code JXG·January 6, 2014
CODMAN VIPV SYSTEM
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·November 5, 2010
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
FDA Enforcement
Class II
·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 2017
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
FDA Recall
Terminated
·Perkinelmer Life Sciences, Inc.·Product code JJN·May 15, 2017
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 15, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·April 1, 2011
CURRENT RF DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
CODMAN VPV SYSTEM
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·January 11, 2018
CODMAN VPV SYSTEM
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·October 1, 2016
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
BIPAP AUTO M-SERIES
FDA Adverse Event
Death
·RESPIRONICS, INC·Product code BZD·July 11, 2012
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 9, 2022
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026