21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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pRESET LITE Thrombectomy Device
FDA 510(k)
FDA Class 2
·Neurology
BD BBL™ Sensi-Disc™ Trimethoprim/Sulfamethoxazole 1.25/23.75 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902315392·BD BBL™ Sensi-Disc™ Trimethoprim/Sulfamethoxazo...
Keeogo Dermoskeleton System
FDA 510(k)
FDA Class 2
·Physical Medicine
HEMOGLOBIN A1C REAGENT SET
FDA 510(k)
FDA Class 2
·Hematology
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
FG6301 DUAL CHNL VOL INFUSION PUMP, 2M8064 RECONDND
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 22, 2011
OCTRODE
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022