Device Directory
Browse 158 FDA-cleared medical devices
HyperVue™ Software (K251198)
Class Class II K251198 NQQ
HESTIA (K243420)
Class Class II K243420 MUE
HyHub™ and HyHub™ Duo Vial Access Devices (K243404)
Class Class II K243404 LHI
HeartFlow Analysis (K250902)
Class Class II K250902 PJA
HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (K243781)
Class Class II K243781 DQK
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968)
Class Class II K251968 KQJ
Heated Breathing Tube (K243244)
Class Class II K243244 BZE
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K250552)
Class Class II K250552 DQX
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire – Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire – Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter – Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire – Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire – Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter – Maximal Barrier kit (70002304); Hydr (K243458)
Class Class II K243458 LJS
HnX-P1, HnX-PB (K251223)
Class Class II K251223 IZL
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