22 results
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18ms
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Sources: EU EUDAMED, US FDA
MILENIA ESTRADIOL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016
PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
FDA 510(k)
FDA Class 2
·Immunology
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·October 6, 2017
MWA PERCUTANEOUS ANTENNA 22CM
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code NEY·November 18, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014
VERSACARE BED
FDA Adverse Event
Other
·HILL-ROM, INC.·Product code FNL·December 19, 2012
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·April 20, 2022
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
FDA Enforcement
Class II
·Terminated·The Binding Site Group, Ltd.·February 1, 2017
Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LCD·October 7, 2009
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
FDA Recall
Terminated
·The Binding Site Group, Ltd.·Product code CFN·September 11, 2014
Human IgG3 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917, Modular P
FDA UDI
THE BINDING SITE GROUP LIMITED·05051700006132·
Human IgG1 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitach
FDA UDI
THE BINDING SITE GROUP LIMITED·05051700007597·
Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P
FDA UDI
THE BINDING SITE GROUP LIMITED·05051700006439·
Hu IgG4 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Modular P
FDA UDI
THE BINDING SITE GROUP LIMITED·05051700006217·Human IgG4 Subclass Liquid Reagent Kit for use ...
Freelite® Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P
FDA UDI
THE BINDING SITE GROUP LIMITED·05051700006316·
Hu IgG Subclass Liquid Reagent Kits for use on Hitachi 911/912/917 and Modular P
FDA UDI
THE BINDING SITE GROUP LIMITED·05051700006064·Human IgG Subclass Liquid Reagent Kits for use ...