23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Eko Electronic Stethoscope System
FDA 510(k)
FDA Class 2
·Cardiovascular
AGXO
FDA UDI
Oticon A/S·05707131288844·H110V2, DESIGNRITE 10 WL THP AGXO
LYSUS INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
IMMULISA DSDNA ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
EXPECT PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·May 19, 2026
EXPECT PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·September 24, 2025
EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·May 26, 2020
ACQUIRE? PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·October 10, 2025
EXPECT PULMONARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·November 14, 2024
EXPECT PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·April 14, 2026
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 7, 2013
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWA·June 30, 2011
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 19, 2023
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 19, 2023
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 19, 2023
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 19, 2023
UNKNOWN CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 3, 2018
ILS 29MM, CURVED
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 3, 2018
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013