80 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
FDA 510(k)
FDA Class 2
·Hematology
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
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756045926·Esophageal Stethoscope w/Temperature Sensor
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
FDA 510(k)
FDA Unclassified
·Unknown
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·September 22, 2010
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·May 18, 2010
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·October 12, 2010
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·April 26, 2010
GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·May 18, 2010
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
CODMAN VPV SYSTEM
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·January 11, 2018
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·September 16, 2010
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·September 9, 2010
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·September 16, 2010
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·July 29, 2010
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·April 9, 2010
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·May 19, 2010