16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PREMISE FLOWABLE
FDA 510(k)
FDA Class 2
·Dental
POSI-LINK
FDA 510(k)
FDA Class 2
·General Hospital
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
FDA 510(k)
FDA Class 2
·Radiology
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013
VISX EXCIMER LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2013
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 17, 2011
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·June 13, 2008
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
FDA Recall
Terminated
·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
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