933 results
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15ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SEBIA PHORESIS
FDA Adverse Event
Malfunction
·SEBIA INC.·Product code JJN·October 21, 2016
HYDRASYS
FDA Adverse Event
Malfunction
·SEBIA INC·Product code JJN·July 19, 2016
SPECIAL DEVICE UNITIZED PROGRA
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·May 7, 2021
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
Apparatus, Electrophoresis, For Clinical Use
FDA classification
FDA Class 1
·Apparatus, Electrophoresis, For Clinical Use
JINS Inc.
FDA registration
JINS Inc.·3 products·🇯🇵 Japan
Acero Z1 Molar
FDA UDI
Park - Istre, LLC·00810120872445·
Acero Z1 Molar
FDA UDI
Park - Istre, LLC·00810120872469·
Acero Z1 Molar
FDA UDI
Park - Istre, LLC·00810120872421·
JENNINGS JAVELIN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
microTargeting™ Electrode
FDA UDI
FHC, INC.·10873263003081·microTargeting(TM) Electrode, backloaded, tungs...
Hemochron Whole Blood Microcoagulation System
FDA UDI
ACCRIVA DIAGNOSTICS HOLDINGS, INC.·10711234540084·Electronic System Verification - Normal
microTargeting™ Electrode
FDA UDI
FHC, INC.·00873263003091·microTargeting(TM) Electrode, backloaded, tungs...
Jin Min Co Ltd
FDA registration
Jin Min Co Ltd·7 products·🇹🇼 Taiwan
JIN CHANG SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
Jan Mao Industries Co., Ltd.
FDA registration
Jan Mao Industries Co., Ltd.·29 products·🇨🇳 China
JIN HSIANG ENT CO. LTD
FDA registration
JIN HSIANG ENT CO. LTD·10 products·🇹🇼 Taiwan
JIN MINNG INDUSTRIAL CO, LTD.
FDA registration
JIN MINNG INDUSTRIAL CO, LTD.·1 product·🇹🇼 Taiwan
KINLee Non-contact Electronic Forehead Infrared Thermomter
FDA UDI
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.·06973337423016·