12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ControlRad Trace Model 8
FDA 510(k)
FDA Class 2
·Radiology
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493944675·AVANOS* Double Needle Set
Halyard
FDA UDI
Avanos Medical, Inc.·10680651944679·
PEN NDL 32G 4MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·December 4, 2020
PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·December 4, 2020
SUINSA DIAGNOSTIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 17, 2014
TOTAL ASR FEM IMP SIZE 53
FDA Adverse Event
DEPUY INTL., LTD. - 8010379·Product code KWA·June 21, 2013
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·July 28, 2011
PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 20, 2021
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024