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Medtronic Navigation, Inc.

76 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCU recall (Z-1022-2025)Medtronic Navigation, Inc.2025-01-27
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation Syste recall (Z-0050-2025)Medtronic Navigation, Inc.2024-10-10
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the Steal recall (Z-1776-2024)Medtronic Navigation, Inc.2024-05-09
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS recall (Z-0698-2024)Medtronic Navigation, Inc.2024-01-10
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS recall (Z-0699-2024)Medtronic Navigation, Inc.2024-01-10
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation Syst recall (Z-0188-2024)Medtronic Navigation, Inc.2023-11-10
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with recall (Z-1630-2023)Medtronic Navigation, Inc.2023-06-02
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems recall (Z-1666-2023)Medtronic Navigation, Inc.2023-06-02
AxiEM" Non-Invasive Patient Tracker recall (Z-1039-2023)Medtronic Navigation, Inc.2023-01-30
RadiaLux Lighted Retractor (Pink), REF: 50-101-1 recall (Z-0953-2023)Medtronic Navigation, Inc.2023-01-12
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. recall (Z-0244-2023)Medtronic Navigation, Inc.2022-11-17
Mazor X Surgical System Positioner Type II, REF: ASM0214-02 recall (Z-2330-2020)Medtronic Navigation, Inc.2020-06-09
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or recall (Z-1995-2020)Medtronic Navigation, Inc.2020-05-18
NavLock Tracker *** Rx Only recall (Z-1693-2020)Medtronic Navigation, Inc.2020-04-10
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Poc recall (Z-0552-2019)Medtronic Navigation, Inc.2018-12-29
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) L recall (Z-2755-2017)Medtronic Navigation, Inc.2017-07-03
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. recall (Z-2746-2017)Medtronic Navigation, Inc.2017-06-26
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed recall (Z-1007-2017)Medtronic Navigation, Inc.2017-01-11
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualas recall (Z-0322-2017)Medtronic Navigation, Inc.2016-10-28
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase B recall (Z-0323-2017)Medtronic Navigation, Inc.2016-10-28
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visuala recall (Z-1672-2016)Medtronic Navigation, Inc.2016-05-16
Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System recall (Z-1088-2016)Medtronic Navigation, Inc.2016-03-08
P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6 recall (Z-2823-2015)Medtronic Navigation, Inc.2015-09-30
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, S recall (Z-2824-2015)Medtronic Navigation, Inc.2015-09-30
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The recall (Z-2324-2015)Medtronic Navigation, Inc.2015-08-03
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU recall (Z-2325-2015)Medtronic Navigation, Inc.2015-08-03
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear pla recall (Z-1847-2015)Medtronic Navigation, Inc.2015-06-26
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kit recall (Z-1794-2015)Medtronic Navigation, Inc.2015-06-12
BAG 9732315 MOUSE STERILE 15 PK recall (Z-1578-2014)Medtronic Navigation, Inc.2014-05-09
BIOPSY NEEDLE KIT, 9733068, PASSIVE recall (Z-1579-2014)Medtronic Navigation, Inc.2014-05-09
BIT 9733516 2.9mm DRILL STERILE recall (Z-1580-2014)Medtronic Navigation, Inc.2014-05-09
DISP 9730950 STRL SPHERE, 1 PK INSERT recall (Z-1581-2014)Medtronic Navigation, Inc.2014-05-09
DISP 9730951 STRL SPHERE, 5PK INSERT recall (Z-1582-2014)Medtronic Navigation, Inc.2014-05-09
DRAPE 9732722 TUBE STERILE O-ARM 20PK recall (Z-1583-2014)Medtronic Navigation, Inc.2014-05-09
ENT PRGM 9734636 ADD FUSION NAV AxiEM recall (Z-1584-2014)Medtronic Navigation, Inc.2014-05-09
INST 9731132 KIT CR REF FRAME DRIVER 5PK recall (Z-1585-2014)Medtronic Navigation, Inc.2014-05-09
INSTRUMENT TRACKER 9733533XOM ENT 1PK recall (Z-1586-2014)Medtronic Navigation, Inc.2014-05-09
KIT, 9731427, THORACIC TACTILE PROBES recall (Z-1587-2014)Medtronic Navigation, Inc.2014-05-09
MOUSE 9732721 STERILE O-ARM 10PK recall (Z-1588-2014)Medtronic Navigation, Inc.2014-05-09
PACK 9731975 TUMOR RESECTION AXIEM CR recall (Z-1589-2014)Medtronic Navigation, Inc.2014-05-09
PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT recall (Z-1590-2014)Medtronic Navigation, Inc.2014-05-09
PATIENT TRACKER 9733534XOM ENT 1PK recall (Z-1591-2014)Medtronic Navigation, Inc.2014-05-09
PIN, 9733235, 100MM, STERILE, PERC REF recall (Z-1592-2014)Medtronic Navigation, Inc.2014-05-09
PIN, 9733236, 150MM, STERILE, PERC REF recall (Z-1593-2014)Medtronic Navigation, Inc.2014-05-09
SHUNT KIT 9733605 NON-INVASIVE recall (Z-1594-2014)Medtronic Navigation, Inc.2014-05-09
SPHERES 8801071 1/TRAY 12PK recall (Z-1595-2014)Medtronic Navigation, Inc.2014-05-09
SPHERES 8801075 5/TRAY 12PK recall (Z-1596-2014)Medtronic Navigation, Inc.2014-05-09
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT recall (Z-1597-2014)Medtronic Navigation, Inc.2014-05-09
TRAJ GUIDE KIT, 9733066, BIOPSY, INT recall (Z-1598-2014)Medtronic Navigation, Inc.2014-05-09
TUMOR RES. PACK 9733553 AxiEM S.M. recall (Z-1599-2014)Medtronic Navigation, Inc.2014-05-09
TUMOR RESECTION KIT 9733607 NON-INVASIVE recall (Z-1600-2014)Medtronic Navigation, Inc.2014-05-09
TUMOR RESECTION KIT 9733608 SKULL MOUNT recall (Z-1601-2014)Medtronic Navigation, Inc.2014-05-09
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION recall (Z-1602-2014)Medtronic Navigation, Inc.2014-05-09
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-0002 recall (Z-0973-2014)Medtronic Navigation, Inc.2014-02-28
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures a recall (Z-1956-2013)Medtronic Navigation, Inc.2013-08-13
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, recall (Z-0926-2013)Medtronic Navigation, Inc.2013-03-08
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set ( recall (Z-0441-2013)Medtronic Navigation, Inc.2012-11-29
Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-7 recall (Z-2244-2012)Medtronic Navigation, Inc.2012-08-22
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027- recall (Z-1849-2012)Medtronic Navigation, Inc.2012-06-21
Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Tracka recall (Z-1189-2012)Medtronic Navigation, Inc.2012-03-08
Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Track recall (Z-1190-2012)Medtronic Navigation, Inc.2012-03-08
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027 recall (Z-0001-2012)Medtronic Navigation, Inc2011-10-03
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 8002 recall (Z-0002-2012)Medtronic Navigation, Inc2011-10-03
DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system ord recall (Z-2781-2011)Medtronic Navigation, Inc.2011-07-11
Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtron recall (Z-1558-2011)Medtronic Navigation, Inc2011-03-04
Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Dri recall (Z-1042-2011)Medtronic Navigation, Inc2011-02-04
Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtroni recall (Z-0715-2011)Medtronic Navigation, Inc2010-12-17
Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Ca recall (Z-0447-2011)Medtronic Navigation, Inc.2010-11-23
Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assis recall (Z-0145-2011)Medtronic Navigation, Inc2010-10-26
Medtronic StealthStation S7 System recall (Z-2029-2010)Medtronic Navigation, Inc2010-07-17
O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medica recall (Z-1998-2010)Medtronic Navigation, Inc.2010-07-13
Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 800 recall (Z-0923-2010)Medtronic Navigation, Inc2010-03-03
Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027 recall (Z-0624-2009)Medtronic Navigation, Inc2009-02-04
BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of recall (Z-2034-2008)Medtronic Navigation, Inc.2008-09-26
Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation recall (Z-0294-2008)Medtronic Navigation, Inc2007-11-27
AxiEM EM Knee Kit, and associated workstation. recall (Z-0718-06)Medtronic Navigation, Inc2006-04-07

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Every clearance here is in the API, with alerts when new ones post.