10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERIPHERAL NERVE BLOCK SUPPORT TRAY
FDA 510(k)
FDA Class 2
·Anesthesiology
KSEA SPINOSCOPE
FDA 510(k)
FDA Class 2
·Orthopedic
VACUCATH I.V. CATHETER INTRODUCTER
FDA 510(k)
FDA Class 2
·General Hospital
SECURESTRAP
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GDW·April 23, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code MMI·April 29, 2011
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
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