Device Directory
Browse 5,064 FDA-cleared medical devices
Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) (K250625)
Class Class II K250625 CAW
Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (K251752)
Class Class II K251752 EOQ
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (K251637)
Class Class II K251637 MQL
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (K251716)
Class Class I K251716 LZA
Vital Signs (K243687)
Class Class II K243687 QME
Fetal & Maternal Monitor (F15A, F15A Air) (K241882)
Class Class II K241882 HGM
ELID (Endoscopic Less Invasive Decompression) System (K243774)
Class Class II K243774 HRX
Phoenix Sinus Tarsi Stent System (K251382)
Class Class II K251382 HWC
VistaSoft 4.0 and VisionX 4.0 (K250947)
Class Class II K250947 QIH
QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (K250080)
Class Class II K250080 QOF
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