FDA.report

MEDTRONIC POWERED SURGICAL SOLUTIONS

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
16255071625507MEDTRONIC POWERED SURGICAL SOLUTIONS1Y2026-01-014620 NORTH BEACH ST. FORT WORTH TX US 76137

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58001071634151K983092TRITON HUDSON CHUCK ATTACHMENTHBB1998-11-06
58001444702752K970965MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)ERL1997-04-09
58001548282022K970023MEDNEXT SURGICAL BURHWE1997-02-28
58001524735040K962483MIDAS REX III MOTORHBB1996-11-19
58001765484047K953434MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)HBB1996-05-16
58001444938946K935861MEDNEXT BURHBE1994-05-03
58001016539285K926547MEDNEXT 1000 BONE DISSECTING SYSTEMHSZ1993-07-22
58001467328607K900388MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINESHBE1990-05-07
58001417288551K870157OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMERKFK1987-02-24
58001532493533K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationOLO2026-02-12
58001298449232K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mmHBE2021-11-23
58001845116790K202552Midas Rex Attachments and Dissecting ToolsOLO2020-11-02
58001705897178K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemHAW2019-11-01
58001705897178K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemHAW2019-11-01
58001022122379K183644Stealth-Midas MR8 SystemOLO2019-05-22
58001197060885K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsHBC2019-05-12
58001937221191K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting toolsHBC2017-05-15
58001468502661K163565MR8 Drill SystemHBC2017-03-28
58002072339154K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesHBB2017-03-23
58001252265047K160713Stealth-Midas SystemOLO2016-05-26
58001165557419K121264TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULEHBE2012-08-27
58002051449725K103775PEAK SUCTION COAGULATORGEI2011-05-27
58001347723578K102709PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICEGEI2010-12-17
58001922460486K093695PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICEGEI2010-04-13
58001342920477K090112MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700HBB2009-03-26
58001678024225K083415PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICEGEI2009-06-05
58001274194944K082786PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICESGEI2008-12-03
58001372254487K081475ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]HBE2008-10-17
58001890859695K081277XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)ERL2008-09-05
58001637614955K073057PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040GEI2008-07-22
58001304185078K072315MIDAS REX CURVED BURHBE2007-09-18
58002000176937K020069MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEMHBB2002-03-18
58001083470054K012456SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)ERL2001-09-21
58001013232123K012453SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)HBC2001-10-22
58001579428321DEN170056Parathyroid Detection (Model PTeye) SystemQDF2018-11-02
580012035061541969-12-31
580012035061541969-12-31
580012035061541969-12-31
580012035061541969-12-31
580013865062581969-12-31
580013865062581969-12-31
580013865062581969-12-31
580013865062581969-12-31
580014912236861969-12-31
580014912236861969-12-31
580014912236861969-12-31
580014912236861969-12-31
580016197927871969-12-31
580016197927871969-12-31
580016197927871969-12-31
580016197927871969-12-31
580017895422191969-12-31
580017895422191969-12-31
580017895422191969-12-31
580017895422191969-12-31
58001536217528
58001789542219
58002000390881

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HBE62021-11-23
HBB62017-03-23
GEI62011-05-27
OLO42026-02-12
HBC42019-05-12
ERL32008-09-05
HAW22019-11-01
QDF12018-11-02
HWE11997-02-28
HSZ11993-07-22
KFK11987-02-24

PMA

PMN

Applications

GUDID

MR8

2026-03-09

MEDTRONIC POWERED SURGICAL SOLUTIONS

Reservoir

2025-08-03

MEDTRONIC POWERED SURGICAL SOLUTIONS

Reservoir

2025-07-31

MEDTRONIC POWERED SURGICAL SOLUTIONS

ENT MR8

2025-07-25

MEDTRONIC POWERED SURGICAL SOLUTIONS

ENT MR8

2025-07-25

MEDTRONIC POWERED SURGICAL SOLUTIONS

ENT MR8

2025-07-25

MEDTRONIC POWERED SURGICAL SOLUTIONS

ENT MR8

2025-07-25

MEDTRONIC POWERED SURGICAL SOLUTIONS

MIDAS REX

2025-03-27

MEDTRONIC POWERED SURGICAL SOLUTIONS