14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
Acapella One
FDA UDI
Choice Spine, LP·00840996151351·ACAPELLA,TRIAL,CX,NS,14X16X11
CARDIOCAM MODEL 9CSY0799
FDA 510(k)
FDA Class 2
·Radiology
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
COVER, BURR HOLE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code GXR·July 1, 2016
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·November 12, 2018
ARCHITECT HAVAB-G
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code LOL·April 22, 2013
UNO
FDA Adverse Event
Injury
·LIKO AB·Product code FSA·April 13, 2011
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·July 9, 2008
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022