24 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Drakon and Sequre Microcatheters
FDA 510(k)
FDA Class 2
·Cardiovascular
MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·January 19, 2024
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 3, 2024
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 3, 2024
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STIMATE N601 TENS
FDA 510(k)
FDA Class 2
·Neurology
MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2022
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 18, 2025
PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 8, 2023
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·July 16, 2025
MUST LT 03.59.234 MUST LT 25MM LONG - PEDICLE SCREW Ø7X40 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·February 16, 2022
MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN
FDA Adverse Event
Death
·MEDACTA INTERNATIONAL SA·Product code NKB·March 29, 2023
BD INSTRUMENT MAX CLINICAL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code OOI·September 21, 2020
CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR
FDA Adverse Event
Malfunction
·ABBOTT MFG, INC.·Product code JIX·October 17, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·July 2, 2013
MUST LT MUST LT 25MM LONG - PEDICLE SCREW 6X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·July 7, 2021
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
MUST LT MUST LT 15MM SHORT - PEDICLE SCREW Ø6X40 CANN
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 3, 2021
MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·June 25, 2024