539 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JWX-2
FDA UDI
SUNRISE MEDICAL (US) LLC·05022408056767·Electric Power assist Unit for Wheelchairs
JWX-2
FDA 510(k)
FDA Class 2
·Physical Medicine
JWX-1 Plus (Navigo 16/Navigo 24)
FDA 510(k)
FDA Class 2
·Physical Medicine
CARTO XP SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD. (HAIFA, ISRAEL)·Product code DQK·February 12, 2009
CHROMID TM STAPH AUREUS AGAR
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JWX·September 11, 2015
LIFESIGN STAPH LATEX
FDA Adverse Event
Malfunction
·NERL DIAGNOSTICS LLC.·Product code JWX·January 15, 2010
WAMPOLE LABORATORIES STAPH LATEX KIT
FDA Adverse Event
Malfunction
·NERL DIAGNOSTICS, LLC·Product code JWX·January 15, 2010
CHROMID S. AUREUS
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JWX·July 2, 2015
API STAPH 25STRIPS+25MEDIA
FDA Adverse Event
Malfunction
·BIOMÉRIEUX, SA·Product code JWX·April 30, 2021
CHROMID SALMONELLA AGAR
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JWX·July 31, 2015
CHROMID SALMONELLA AGAR
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JWX·May 6, 2020
ID 32 STAPH 25STRIPS - 32500
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JWX·August 12, 2021
CHROMID® STAPH AUREUS
FDA Adverse Event
Malfunction
·BIOMÉRIEUX ESPAÑA·Product code JWX·December 30, 2016
CHROMID® STAPH AUREUS
FDA Adverse Event
Malfunction
·BIOMÉRIEUX ESPAÑA·Product code JWX·September 2, 2016
CHROMID® S AUREUS AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JWX·May 19, 2016
CHROMID (TM) SA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JWX·October 5, 2015
Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051 Manufactured for Lifesign LLC , Somerset, NJ 08873 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
FDA Recall
Terminated
·NERL Diagnostics Corporation·Product code JWX·January 15, 2010
Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke, Hants, UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
FDA Recall
Terminated
·Remel, Inc·Product code JWX·July 20, 2009
Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
FDA Recall
Terminated
·Remel, Inc·Product code JWX·October 7, 2008
API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWX·November 9, 2022