277 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZELTIQ CoolSculpting System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221044808·Unitek(TM) Molar Band General Purpose Narrow Re...
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290525·Denovo general purpose dental molar band - Mand...
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
FDA 510(k)
FDA Class 2
·Radiology
ARCHITEX SPACE MAINTENANCE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·September 7, 2021
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·December 20, 2017
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·March 14, 2019
FCG KIT, NEEDLE, BIOPSY
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·April 6, 2020
FCG KIT, NEEDLE, BIOPSY
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·April 7, 2020
FCG KIT, NEEDLE, BIOPSY
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·April 6, 2020
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·November 23, 2017
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·December 9, 2020
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 10, 2013
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·June 2, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·April 30, 2018
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 6, 2020
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·November 9, 2017
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·November 21, 2018