13 results
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30ms
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Sources: EU EUDAMED, US FDA
CRANE USA
FDA registration
CRANE USA·1 product·🇺🇸 United States
DELTA Q
FDA Adverse Event
Malfunction
·PELTON & CRANE·Product code FLE·April 13, 2018
CRANE WARM MIST HUMIDIFIER, PRODUCT NUMBER EE-5200B
FDA Adverse Event
CRANE USA·Product code KFZ·April 3, 2017
CRANE
FDA Adverse Event
CRANE USA·Product code KFZ·February 14, 2017
CONNECTA PLUS3 16CM WHITE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·September 19, 2025
CONNECTA PLUS3 16CM WHITE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·September 10, 2025
CONNECTA PLUS3 16CM WHITE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·September 19, 2025
CONNECTA PLUS3 16CM WHITE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·September 19, 2025
Omnera 400T Digital Radiographic System
FDA Recall
Open, Classified
·Arcoma AB Annavagen·Product code KPR·May 5, 2021
Omnera 400A Digital Radiographic System
FDA Recall
Open, Classified
·Arcoma AB Annavagen·Product code KPR·May 5, 2021
HELIOS 3000 TRACK MOUNT LIGHT
FDA Adverse Event
Malfunction
·PELTON & CRANE·Product code EAZ·October 24, 2013
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc·May 11, 2016
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.
FDA Recall
Terminated
·Carestream Health Inc·Product code LLZ·April 15, 2016