11 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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The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.
FDA 510(k)
FDA Class 2
·Microbiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017989·K-Wire, Single Ended, Trocar Point, Diameter Si...
SacroFuse
FDA UDI
SPINEFRONTIER, INC.·00190361029199·Ø12mm X 45mm Hybrid Fusion Screw, Gen II
DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
FDA 510(k)
FDA Class 2
·Radiology
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 10, 2014
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 9, 2011
D'VINCI SI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC.·Product code NAY·July 16, 2013
21 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION
FDA Adverse Event
Injury
·BECTON DICKINSON, S.A.·Product code FMI·September 8, 2017
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025