843 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOGIC KNEE COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 30, 2021
PASCO MICRO-ORGANISM SUSCEPTIBILITY SYSTEM
FDA Adverse Event
Malfunction
·DIFCO·Product code LKA·April 21, 1995
UNKNOWN
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code GEX·July 1, 2025
MEDTRONIC NAVIGATION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 9, 2020
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
FDA Recall
Terminated
·Remel Inc·Product code LKA·February 9, 2017
BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton, Dickinson and Company, Sparks, MD 21152 USA 38800 Le Pont de Claix, France. Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code LKA·January 11, 2012
BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton, Dickinson and Company, Sparks, MD 21152 USA 38800 Le Pont de Claix, France. Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code LKA·January 11, 2012
Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.
FDA Recall
Terminated
·Diagnostic Hybrids Inc·Product code LKA·December 31, 2012
BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton, Dickinson and Company, Sparks, MD 21152 USA 38800 Le Pont de Claix, France. Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code LKA·January 11, 2012
Culture Media, Antimicrobial Susceptibility Test
FDA classification
FDA Class 2
·Culture Media, Antimicrobial Susceptibility Test
Hercules Air Mattress Controller
FDA UDI
MOREL COMPANY, LLC., THE·00819552022343·Controller, Kap Medical, Revision A
STEPAC L.A., LTD.
FDA registration
STEPAC L.A., LTD.·1 product·🇮🇱 Israel
FKA Distributing Co., LLC
FDA registration
FKA Distributing Co., LLC·13 products·🇺🇸 United States
FKA Distributing Co., LLC
FDA registration
FKA Distributing Co., LLC·20 products·🇺🇸 United States
BK-A
FDA UDI
BIOTRONIK SE & Co. KG·04035479144739·
MEDCURA, INC. (FKA GEL-E, INC.)
FDA registration
MEDCURA, INC. (FKA GEL-E, INC.)·1 product·🇺🇸 United States
Sonablate Corp. (FKA) SonaCare Medical, LLC
FDA registration
Sonablate Corp. (FKA) SonaCare Medical, LLC·1 product·🇺🇸 United States
Orantech
FDA UDI
Orantech Inc.·06941691946168·Suction Electrode Adapter Sets, 6pcs/Box
Orantech
FDA UDI
Orantech Inc.·06941691946151·Suction Electrode Adapter Sets, 6pcs/Box
Carerite®
FDA UDI
STEPAC L.A. LTD.·07290016678017·2" Sterilization Tubing Cont Clr