FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
IYN
2025-05-30
HGX
2025-05-30
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
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POV
2025-05-30
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
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NGX
2025-05-30
XBody Go USA, XBody Pro USA
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QUW
2025-05-30
TekBrace Solo Soft Tissue Reinforcement Device
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HGX
2025-05-30
Wearable Breast Pump (Model S21)
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FXX
2025-05-30
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce
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KDI
2025-05-30
5008X Hemodialysis System
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DTR
2025-05-30
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
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QIH
2025-05-30
AudaxCeph Cephalogram Analysis Software
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NDN
2025-05-30
VCFix Spinal System
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OHS
2025-05-30
KALA Red Light Face Mask (KALA-01)
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