FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
DXN
2026-05-06
EBI
2026-05-06
Denture Base
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OVD
2026-05-05
MectaLIF 3D Metal Anterior
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IYN
2026-05-05
Lumify Diagnostic Ultrasound System
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IRP
2026-05-05
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)
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OHT
2026-05-05
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
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IYN
2026-05-05
Healium Intelliscan LX192LC
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NKB
2026-05-05
AccelFix Spinal Fixation System
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OMP
2026-05-04
Wound Geni NPWT System
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GEX
2026-05-04
Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)
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SHW
2026-05-04
ArteraAI Breast
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FPA
2026-05-04
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
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