153 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 22, 2015
Shield, Vial
FDA classification
FDA Class 1
·Shield, Vial
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
FDA Enforcement
Class II
·Terminated·GE Healthcare·April 11, 2018
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 19, 2019
GWW
FDA registration
GWW·17 products·🇩🇪 Germany
ITW FILTERTEK
FDA registration
ITW FILTERTEK·1 product·🇺🇸 United States
Drive
FDA UDI
Drive Devilbiss Healthcare·00822383146287·Walker, AdltHD, 2Btn w/Whls, 2/cs
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·00822383901145·Walkers, All TypesBariatric Product Description...
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·50822383973444·Walkers, All Types2-Button Alum Product Descrip...
WW-West
FDA registration
WW-West·1 product·🇺🇸 United States
FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)
FDA registration
FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)·1 product·🇮🇪 Ireland
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·00612479223059·Walkers, All TypesBariatric Product Description...
Resona I8W Diagnostic Ultrasound System
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06903053044073·
Nuewa I8W Diagnostic Ultrasound System
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06903053044356·
Resona I9W Diagnostic Ultrasound System
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06936415987978·
ALG WW LLC
FDA registration
ALG WW LLC·2 products·🇺🇸 United States
WW GROUP UK
FDA registration
WW GROUP UK·1 product·🇮🇳 India
ETEST ESBL CT/CTL 16/1 WW B30
FDA Adverse Event
Malfunction
·BIOMÉRIEUX, SA·Product code JWY·March 11, 2021
0800,APS0,08,AV,N,LT,ICW
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828153294·0800,APS0,08,AV,N,LT,ICW
BASSINET, EURO STYLE
FDA Adverse Event
Malfunction
·IWC·Product code FMS·November 16, 2011