25 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
FDA 510(k)
FDA Class 1
·Physical Medicine
COULTER A T 5DIFF CAP PIERCE (CP)
FDA 510(k)
FDA Class 2
·Hematology
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
ELECTRIC PEN DRIVE, 60,000 RPM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 5, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013
UNICEL DXC 600 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·May 26, 2011
BD PHOENIX PMIC110
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·October 19, 2021
BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·August 23, 2021
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
BD PHOENIX PANEL PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
BD PHOENIX PANEL PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023
ESOPHYX Z
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015