11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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eQUANT System
FDA 510(k)
FDA Class 2
·Microbiology
BD BBL™ Sensi-Disc™ Trimethoprim/Sulfamethoxazole 1.25/23.75 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902315360·BD BBL™ Sensi-Disc™ Trimethoprim/Sulfamethoxazo...
BRAIN COIL, MODEL 9900GE-64
FDA 510(k)
FDA Class 2
·Radiology
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·February 17, 2020
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
ADVANTAGE SERIES 26 OBS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 22, 2011
SINGLE EXTENSION
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
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