10 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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Intimate Rose Vaginal Dilators
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695502P241748S1·PLIF 24mm x 8mm x 17mm x 4 °, TyPEEK, Sterile
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695302P241748S1·PLIF 24mm x 8mm x 17mm x 4 °, PEEK, Sterile
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 20, 2024
SOVEREIGN SYSTEM
FDA Adverse Event
Injury
·ADVANCED MEDICAL OPTICS (AMO)·Product code HQC·November 19, 2008
NEUROMONITOR BASIC KIT
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF - MEDOS·Product code GWM·September 9, 2011
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 22, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025