631 results
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54ms
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Sources: EU EUDAMED, US FDA
CARROM 2002-20
FDA Adverse Event
Death
·MED SERVICE, INC.·Product code FNJ·April 7, 1999
CBYON
FDA UDI
MED-SURGICAL SERVICES, INC.·00860008782700·An electrically-powered computer-aided image-gu...
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
Z800WF
FDA Adverse Event
Malfunction
·ZYNO MEDICAL, LLC·Product code FRN·January 22, 2026
SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·November 10, 2010
LEICA MICROSYSTEMS
FDA Adverse Event
Malfunction
·LEICA MICROSYSTEMS (SCHWEIZ) AG·Product code EPT·August 25, 2016
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Recall
Terminated
·POM Medical LLC·Product code BYG·July 11, 2018
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·January 31, 2011
EVIS EXERA II COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·August 1, 2023
SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·November 10, 2010
SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·November 10, 2010
SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·November 10, 2010
OXYGEN BLENDER C3#83307
FDA Adverse Event
Malfunction
·BIO-MEDICAL·Product code BZR·August 12, 2023
BIANCA
FDA Adverse Event
Malfunction
·ARJO MED AB LTD.·Product code FSA·July 17, 2012
MAXIMOVE (GLOUCESTER)
FDA Adverse Event
Malfunction
·ARJO MED AB LTD.·Product code FSA·August 28, 2012
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 2, 2011
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 2, 2011
MARISA
FDA Adverse Event
Malfunction
·ARJO MED AB LTD·Product code FSA·September 11, 2012
DYNA MED INC.
FDA Adverse Event
Malfunction
·DYNA MED INC.·Product code HST·February 22, 2007
OPERA
FDA Adverse Event
Injury
·ARJO MED AB LTD·Product code FSA·October 4, 2012