Device Directory
Browse 151 FDA-cleared medical devices
Portable Oxygen Concentrator (Spirit-3) (K242736)
Class Class II K242736 CAW
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (K243956)
Class Class II K243956 CCK
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (K242921)
Class Class II K242921 BTO
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (K251499)
Class Class II K251499 BTR
Happy Health Home Sleep Test (K242224)
Class Class II K242224 MNR
F&P Nova Nasal Mask (K243583)
Class Class II K243583 BZD
AdheResp Smart Breath-actuated Mesh Nebulizer (K250583)
Class Class II K250583 CAF
WiTOF (K243339)
Class Class II K243339 KOI
Optiflow+ Nasal Cannula – Small (OPT942); Optiflow+ Nasal Cannula – Medium (OPT944); Optiflow+ Nasal Cannula – Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) (K251611)
Class Class II K251611 BTT
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (K250774)
Class Class II K250774 BSP
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