15 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Publix Short Needle Insulin Syringe
FDA UDI
PUBLIX SUPER MARKETS, INC.·10041415024783·Publix 1/2cc, 5/16 inch x 31 gauge insulin syri...
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583033143·ET20, KIT 13 NFM R BE ENCHANT 20
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123267·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 100mm
TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
FDA 510(k)
FDA Class 2
·Radiology
HEMOSIL PROTEIN S ACTIVITY ASSAY
FDA 510(k)
FDA Class 2
·Hematology
DUETTO MT
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·April 14, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
CASTVAC W/8 FOOT HOSE AND MOBILE STAND
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code LGH·June 27, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 4, 2011
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023