FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
FRC
2025-08-04
DXN
2025-08-04
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
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KFM
2025-08-04
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
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IZL
2025-08-04
HnX-P1, HnX-PB
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MPN
2025-08-04
CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)
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JWO
2025-08-04
Blood Volume Analyzer (200)
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IYO
2025-08-01
Deepsight NeedleVue LC1 Ultrasound System
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NOM
2025-08-01
MycoMEIA Aspergillus Assay
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KPE
2025-08-01
eZSURE™ Empty Fluid Container
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EGM
2025-08-01
QuickSleeper 5
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HTY
2025-08-01
RONAVIS – FX (FX-001)
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SAH
2025-08-01
Self-Forming Magnet (Flexagon Plus OTOLoc)
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