FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
LPL
2025-07-02
IWB
2025-07-02
Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)
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PZL
2025-07-02
CS-Pro MED
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OXO
2025-07-02
Orthoscan TAU Mini C-Arm
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POK
2025-07-01
StrokeSENS ASPECTS Software Application
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MBI
2025-07-01
SnugFit ASA Extension
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NKB
2025-07-01
Momentum® Posterior Spinal Fixation System
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FET
2025-07-01
Endoscopic Camera System
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EZD
2025-07-01
Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)
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LJS
2025-07-01
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
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QIH
2025-07-01
Bunkerhill Abdominal Aortic Quantification (AAQ)
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QRK
2025-07-01
droplet® personal lancets
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