ClearanceBrief
Company ยท US

Medtronic Navigation, Inc.-Littleton

FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2010. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
20recalls (0 in 12 months)
20recalls that name a 510(k)

Product codes

CodeDeviceRecords
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile14
OWBInterventional Fluoroscopic X-Ray System7

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 17, 2010K092564O-ARM IMAGING SYSTEM
Medtronic Navigation, Inc. (Littleton)
OXO

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 6, 2024Medtronic Navigation, Inc.-Littleton
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Open, Classified
OWBK151000
Aug 24, 2023Medtronic Navigation, Inc.-Littleton
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater
Open, Classified
OWBK151000
Dec 31, 2019Medtronic Navigation, Inc.-Littleton
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Terminated
OWBK151000
K173664
May 1, 2019Medtronic Navigation, Inc.-Littleton
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM AS
Terminated
OXOK092564
Sep 17, 2018Medtronic Navigation, Inc.-Littleton
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
Terminated
OWBK173664
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoro
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopi
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluorosco
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic a
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluo
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluorosco
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an
Terminated
OXOK092564
Aug 30, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3
Terminated
OXOK092564
Jan 25, 2018Medtronic Navigation, Inc.-Littleton
O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS
Terminated
OXOK092564
Sep 30, 2017Medtronic Navigation, Inc.-Littleton
O-arm O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatri
Terminated
OWBK151000
Oct 11, 2016Medtronic Navigation, Inc.-Littleton
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is de
Terminated
OWBK151000
Mar 17, 2016Medtronic Navigation, Inc.-Littleton
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Terminated
OWBK151000
Mar 17, 2016Medtronic Navigation, Inc.-Littleton
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Terminated
OXOK092564
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