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
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2024 | Medtronic 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 |
OWB | K151000 |
| Aug 24, 2023 | Medtronic 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 |
OWB | K151000 |
| Dec 31, 2019 | Medtronic Navigation, Inc.-Littleton O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 Terminated |
OWB | K151000 K173664 |
| May 1, 2019 | Medtronic 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 |
OXO | K092564 |
| Sep 17, 2018 | Medtronic 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 |
OWB | K173664 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Aug 30, 2018 | Medtronic 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 |
OXO | K092564 |
| Jan 25, 2018 | Medtronic 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 |
OXO | K092564 |
| Sep 30, 2017 | Medtronic 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 |
OWB | K151000 |
| Oct 11, 2016 | Medtronic 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 |
OWB | K151000 |
| Mar 17, 2016 | Medtronic Navigation, Inc.-Littleton Medtronic Navigation O-arm 02 surgical x-ray imaging system Terminated |
OWB | K151000 |
| Mar 17, 2016 | Medtronic Navigation, Inc.-Littleton Medtronic 0-arm Imaging mobile x-ray system.
Model Numbers - B1-700-00027,
B1-700-00028 Terminated |
OXO | K092564 |