Autorizaciones FDA 510(k)
Dispositivos autorizados mediante 510(k) seguidos por MedTracker
HGX
2026-04-06
IYN
2026-04-06
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
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KWD
2026-04-03
HYALEX® MTP Hemiarthroplasty Implant
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ETB
2026-04-03
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);
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ETA
2026-04-03
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50
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NKB
2026-04-03
KHEIRON® Spinal Fixation System, including patient specific K-ROD
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DXC
2026-04-03
Life Saving Tourniquet
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HWC
2026-04-03
Tyber Medical Trauma Screw
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QPB
2026-04-03
LSSA (NP-200)
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IYE
2026-04-03
ClearCheck (RADCC V2.7)
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HGX
2026-04-03
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
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GXY
2026-04-03
Ceribell Brain Monitor Headband
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