10 results · 16ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

FDA Enforcement
Class II ·Terminated·Medtronic Navigation, Inc.-Littleton·January 8, 2020

Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

FDA Enforcement
Class II ·Terminated·Covidien Llc·November 17, 2021

Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

FDA Enforcement
Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021

Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

FDA Enforcement
Class II ·Terminated·Ortho Solutions Inc·August 9, 2017

Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

FDA Enforcement
Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021

Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use

FDA Enforcement
Class II ·Terminated·Medtronic Neurosurgery·October 3, 2018

Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

FDA Enforcement
Class II ·Terminated·RF Technologies, Inc.·July 3, 2013

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 ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE OARM Bl70000027100R SYSTEM lOOV RWK Bl70000027100R BASE OARM 8170000027120 SYSTEM 120V 8170000027120 BASE OARM Bl70000027120R SYSTEM 120V RWK BI70000027120R BASE OARM Bl70000027230 SYSTEM 230V 8170000027230 BASE OARM Bl70000027230R SYSTEM 230V RWK BI70000027230R OARM ASSY BI70000027GER SYS PRODUCT GER BI70000027GER OARM ASSY Bl70000027GERR SYS PRODUCT REFURB BI70000027GERR BASE OARM 8170000028100 SYS lOOV 8170000028100 BASE OARM BI70000028120 SYS 120V 8170000028120 BASE OARM BI70000028120R 3RD EDIT REFURB BI70000028120R BASE OARM BI70000028230 SYS 230V BI70000028230 BASE OARM BI70000028230R 3RD EDIT REFURB Bl70000028230R Product Usage: The 0-arrn Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomi~ structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

FDA Enforcement
Class II ·Terminated·Medtronic Navigation, Inc.-Littleton·July 10, 2019

Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

FDA Enforcement
Class II ·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·September 27, 2017

Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

FDA Enforcement
Class II ·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·September 27, 2017