631 results · 54ms · Sources: EU EUDAMED, US FDA

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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