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Browse 561 FDA-cleared medical devices

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561 devices

EnSite™ X EP System (K251234)

Class Class II K251234 DQK
2025-07-30

BeneVision Central Monitoring System (K242728)

Class Class II K242728 MSX
2025-07-31

iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr (K251113)

Class Class II K251113 DXN
2025-08-04

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) (K251762)

Class Class II K251762 KFM
2025-08-04

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) (K251120)

Class Class II K251120 DXN
2025-08-06

Cardiologs Holter Platform (K250569)

Class Class II K250569 DPS
2025-08-06

Coretech Compression System (Coretech RHB3003) (K250817)

Class Class II K250817 JOW
2025-08-08

Eko Foundation Analysis Software with Transformers (EFAST) (K251494)

Class Class II K251494 DQD
2025-08-12

Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) (K250931)

Class Class II K250931 DQA
2025-08-13

Zio® monitor (DFG0001) (K243650)

Class Class II K243650 DSH
2025-08-15
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