FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
FBK
2025-12-02
SGT
2025-12-02
Aura Wave
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KPS
2025-12-01
Cartesion Prime (PCD-1000A/3) V10.21
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DQA
2025-12-01
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
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OLI
2025-12-01
Led Light Phototherapy Bed (Pro 450/ GY-680A)
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DQA
2025-12-01
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
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PEK
2025-12-01
Minuteman® G6 MIS Fusion Plate
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KWT
2025-12-01
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
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DSA
2025-12-01
IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)
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JXG
2025-11-28
Sophy Mini Monopressure Valve (SM1)
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GEX
2025-11-28
Medical Diode Laser Systems (TR-B)
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JAK
2025-11-28
CT VScore+
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