FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
MQK
2025-01-31
LCX
2025-01-31
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
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HWC
2025-01-31
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
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JDR
2025-01-31
Arthrex DynaNite Nitinol Staples
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IRP
2025-01-31
Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La
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DQO
2025-01-31
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
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LLZ
2025-01-31
ZeTTA PACS
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INI
2025-01-31
Mobility Scooter (MS160A)
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LZA
2025-01-31
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
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MBI
2025-01-31
Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)
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FED
2025-01-31
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
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SCR
2025-01-31
Nuance Audio Hearing Aid Software
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