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Sterilmed, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories5
Latest FDA decision2026-06-29
TypeNumberDevice NameCodeDateActions
510(k) K254149 Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)OWQ2026-06-29 View
510(k) K240826 Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterNLH2024-10-11 View
510(k) K190478 Reprocessed ViewFlex™ Xtra ICE CatheterOWQ2019-11-14 View
510(k) K190610 Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ2019-08-15 View
510(k) K182272 Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ2019-04-15 View
510(k) K161700 SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound CathetersOWQ2016-11-21 View
510(k) K161086 Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)NUJ2016-09-20 View
510(k) K153006 Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH2016-06-23 View
510(k) K152090 Reprocessed Steerable IntroducerPNE2016-03-23 View
510(k) K152134 Reprocessed Vessel SealerNUJ2016-01-15 View
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