Device Directory
Browse 561 FDA-cleared medical devices
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (K241728)
Class Class II K241728 DXN
Rotarex Atherectomy System (K242757)
Class Class II K242757 MCW
Wrist Blood Pressure Monitor (OHMS11, OHMS12) (K242568)
Class Class II K242568 DXN
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (K233956)
Class Class II K233956 DQA
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (K241334)
Class Class II K241334 LDF
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (K242966)
Class Class II K242966 DQO
Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) (K241590)
Class Class II K241590 DXN
iCare APP (K243146)
Class Class II K243146 MWI
Accurate Mini Non-invasive blood pressure monitor (AMB-001) (K242352)
Class Class II K242352 DXN
Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) (K242580)
Class Class II K242580 DQA
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