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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K183644

Stealth-Midas MR8 System · Medtronic Powered Surgical Solutions · decided 2019-05-22 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
MR8 Stealth-MidasPM800N-RMEDTRONIC PS MEDICAL, INC.HAW00763000063979
Midas Rex MR8CA875MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ00763000374730
Midas Rex MR8CA875MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ00643169912205
MIDAS REX MR8EM800MEDTRONIC POWERED SURGICAL SOLUTIONSERL HBC00763000430917
MIDAS REX STEALTH-MIDAS MR8PM800NMEDTRONIC POWERED SURGICAL SOLUTIONSHAW OLO00763000431020
Midas Rex MR8PM800NMEDTRONIC POWERED SURGICAL SOLUTIONSHAW OLO00643169912168
MR8 Stealth-MidasEM800N-RMEDTRONIC PS MEDICAL, INC.HAW00763000063337
MIDAS REX STEALTH MIDAS MR8EM800NMEDTRONIC POWERED SURGICAL SOLUTIONSHAW OLO00763000430924
Midas Rex MR8EM800NMEDTRONIC POWERED SURGICAL SOLUTIONSHAW OLO00643169912151
MIDAS REX MR8PM800MEDTRONIC POWERED SURGICAL SOLUTIONSERL HBB00763000431013