16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
FDA 510(k)
FDA Class 2
·Cardiovascular
TENS CARE, MODEL XL-Y3
FDA 510(k)
FDA Class 2
·Neurology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 30, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·April 29, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 25, 2008
CONVECTIVE PATIENT WARMER
FDA Adverse Event
Malfunction
·STRYKER CORP DBA GAYMAR·Product code DWJ·April 13, 2011
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020
UNFOLDER PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021